Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-05 @ 5:23 PM
Study NCT ID:
NCT05279651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ivabradine for Prevention of Myocardial Injury After Noncardiac Surgery Trial (PREVENT-MINS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-12', 'releaseDate': '2025-11-19'}], 'estimatedResultsFirstSubmitDate': '2025-11-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077550', 'term': 'Ivabradine'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2146}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-03-04', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiac revascularization', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who undergo cardiac revascularization'}, {'measure': 'Re-hospitalization for vascular reasons', 'timeFrame': '30 days after randomization', 'description': 'Number of patients re-hospitalized for vascular reasons'}, {'measure': 'Acute myocardial injury according to Fourth Universal Definition of Myocardial Infarction', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience an acute myocardial injury according to Fourth Universal Definition of Myocardial Infarction'}, {'measure': 'Non-fatal cardiac arrest', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience non-fatal cardiac arrest'}, {'measure': 'Acute congestive heart failure', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience acute congestive heart failure'}, {'measure': 'Any symptomatic or asymptomatic episode of deep vein thrombosis or pulmonary embolism', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience any (symptomatic or asymptomatic) episode of deep vein thrombosis or pulmonary embolism'}, {'measure': 'International Society on Thrombosis and Haemostasis (ISTH) major bleeding', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience major bleeding (as defined by ISTH)'}, {'measure': 'BIMS', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience bleeding independently associated with mortality after noncardiac surgery (BIMS)'}, {'measure': 'Infection/Sepsis', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience infection/sepsis'}, {'measure': 'Acute kidney injury fulfilling Kidney Disease Improving Global Outcomes (KDIGO) criteria', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience an acute kidney injury (fulfilling KDIGO criteria)'}, {'measure': 'Acute kidney injury requiring dialysis', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience an acute kidney injury requiring dialysis'}, {'measure': 'Amputation', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who undergo an amputation'}, {'measure': 'Days outside of intensive care unit', 'timeFrame': '30 days after randomization', 'description': 'Average number of days alive outside of intensive care/cardiac care unit within 30 days after randomization'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days after randomization', 'description': 'Average length of hospital stay'}, {'measure': 'Length of intensive care unit stay', 'timeFrame': '30 days after randomization', 'description': 'Average length of intensive care unit stay'}, {'measure': 'Discharge destination from the hospital', 'timeFrame': '30 days after randomization', 'description': 'Number of patients discharge to home/long-term care facility/other'}, {'measure': 'All-cause mortality', 'timeFrame': '1 year after randomization', 'description': 'Number of patients who die of any cause'}, {'measure': 'Vascular death', 'timeFrame': '1 year after randomization', 'description': 'Number of patients who die of vascular cause'}, {'measure': 'Myocardial infarction', 'timeFrame': '1 year after randomization', 'description': 'Number of patients who experience a myocardial infarction'}, {'measure': 'Cardiac revascularization', 'timeFrame': '1 year after randomization', 'description': 'Number of patients who undergo cardiac revascularization'}, {'measure': 'Non-fatal cardiac arrest', 'timeFrame': '1 year after randomization', 'description': 'Number of patients who experience non-fatal cardiac arrest'}, {'measure': 'Stroke', 'timeFrame': '1 year after randomization', 'description': 'Number of patients who experience a stroke'}, {'measure': 'Health-related quality of life', 'timeFrame': '1 year after randomization', 'description': 'Average health-related quality of life (based on EuroQol 5 Dimension, five-level version \\[EQ-5D\\])'}, {'measure': 'Amputation', 'timeFrame': '1 year after randomization', 'description': 'Number of patients who have an amputation'}, {'measure': 'Re-hospitalization for vascular reasons', 'timeFrame': '1 year after randomization', 'description': 'Number of patients who experience a re-hospitalization for vascular reasons'}], 'primaryOutcomes': [{'measure': 'MINS', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience myocardial injury after non-cardiac surgery (MINS) defined as any myocardial infarction and any elevated postoperative cardiac troponin judged as resulting from myocardial ischaemia during or within 30 days after noncardiac surgery.'}], 'secondaryOutcomes': [{'measure': 'A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who have at least one of the following: vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest'}, {'measure': 'MINS not fulfilling the 4th universal definition of myocardial infarction', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience MINS not fulfilling the 4th universal definition of myocardial infarction'}, {'measure': 'Myocardial infarction', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience a myocardial infarction'}, {'measure': 'Vascular death', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who die of vascular cause'}, {'measure': 'Stroke', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience a stroke'}, {'measure': 'All-cause mortality', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who die of any cause'}, {'measure': 'Days alive and at home', 'timeFrame': '30 days after randomization', 'description': 'Average number of days when a patient is alive and out of hospital within 30 days after randomization'}, {'measure': 'Health-related quality of life', 'timeFrame': '30 days after randomization', 'description': 'Average health-related quality of life (based on EuroQol 5 Dimension, five-level version \\[EQ-5D\\])'}, {'measure': 'Clinically important atrial fibrillation', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience clinically important atrial fibrillation'}, {'measure': 'Clinically significant bradycardia', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience clinically significant bradycardia'}, {'measure': 'Clinically significant hypotension', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience clinically significant hypotension'}, {'measure': 'Phosphenes', 'timeFrame': '30 days after randomization', 'description': 'Number of patients who experience phosphenes'}, {'measure': "Cancellation or postponement of surgery due to concerns about patient's heart rate", 'timeFrame': '30 days after randomization', 'description': 'Number of surgeries cancelled or postponed due to heart rate concerns'}, {'measure': 'Peak troponin concentration', 'timeFrame': '30 days after randomization', 'description': 'Peak troponin concentration during the index hospitalization'}, {'measure': 'Area under the curve troponin', 'timeFrame': '30 days after randomization', 'description': 'Area under the curve of troponin concentrations measured during the hospitalization'}, {'measure': 'Intraoperative mean arterial pressure', 'timeFrame': '30 days after randomization', 'description': 'Intraoperative mean arterial pressure measured during the index surgery to calculate the average intraoperative mean arterial pressure'}, {'measure': 'Intraoperative heart rate', 'timeFrame': '30 days after randomization', 'description': 'Intraoperative heart rate measured during the index surgery to calculate the average heart rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial ischemia', 'Randomized controlled trial', 'Blinded', 'Noncardiac surgery', 'Cardiovascular events', 'Myocardial injury after non-cardiac surgery', 'Perioperative myocardial injury', 'Perioperative myocardial infarction', 'Perioperative medicine', 'Heart rate', 'Ivabradine', 'Cardiovascular Diseases', 'Troponin', 'Perioperative care', 'Physiological Effects of Drugs', 'Cardiovascular Agents', 'Cardiac Chronotropy', 'Heart Rate Control'], 'conditions': ['Myocardial Injury After Noncardiac Surgery (MINS)', 'Myocardial Ischemia']}, 'referencesModule': {'references': [{'pmid': '41272750', 'type': 'DERIVED', 'citation': 'Szczeklik W, Fronczek J, Putowski Z, Wludarczyk A, Gorka J, Seczynska B, Gryszowka D, Widawska A, Bialka S, Palaczynski P, Borys M, Kutnik P, Czarnik T, Krolicki T, Szczepanska A, Hajder N, Mozanski M, Onichimowski D, Kotfis K, Trzebicki J, Sadowski L, Solek-Pastuszka J, Grudzien P, Mudyna W, Misiewska-Kaczur A, Owczuk R, Kudlinski B, Studzinska D, Pawlik J, Makowski A, Zietkiewicz M, Przydacz M, Gozdzik W, Gola W, Jasiewicz P, Zhao Z, Shyr Y, Devereaux PJ. Ivabradine for prevention of myocardial injury after noncardiac surgery (PREVENT-MINS trial): study protocol for a randomized controlled trial. Trials. 2025 Nov 21;26(1):533. doi: 10.1186/s13063-025-09087-z.'}, {'pmid': '40884771', 'type': 'DERIVED', 'citation': 'Szczeklik W, Fronczek J, Putowski Z, Wludarczyk A, Gorka J, Seczynska B, Gryszowka D, Widawska A, Bialka S, Palaczynski P, Borys M, Kutnik P, Czarnik T, Szczepanska A, Mozanski M, Mieszkowski M, Kotfis K, Trzebicki J, Sadowski L, Solek-Pastuszka J, Grudzien P, Mudyna W, Misiewska-Kaczur A, Owczuk R, Kudlinski B, Studzinska D, Pawlik J, Makowski A, Zietkiewicz M, Przydacz M, Gozdzik W, Gola W, Jasiewicz P, Zhao Z, Shyr Y, Devereaux PJ; PERI-CRIT Investigators. Ivabradine in Patients Undergoing Noncardiac Surgery: A Randomized Controlled Trial. Circulation. 2025 Oct 21;152(16):1126-1135. doi: 10.1161/CIRCULATIONAHA.125.076704. Epub 2025 Aug 30.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multicentre, randomized controlled trial of ivabradine versus placebo.', 'detailedDescription': 'The PREVENT-MINS study is a 2,500 patient multicentre, superiority randomized controlled trial of ivabradine versus placebo. The primary objective of the trial is to determine the impact of ivabradine versus placebo on the risk of MINS in patients with or at risk of atherosclerotic disease who are followed for 30 days after noncardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Undergoing noncardiac surgery\n2. ≥45 years of age\n3. Expected to require at least an overnight hospital admission after surgery\n4. Provide written informed consent to participate in the PREVENT-MINS Trial, AND\n5. Fulfill ≥1 of the following 5 criteria (A-E):\n\nA. History of coronary artery disease B. History of peripheral arterial disease C. History of stroke D. Undergoing major vascular surgery, OR\n\nE. Any 3 of 9 risk criteria:\n\ni. Undergoing major surgery ii. History of congestive heart failure iii. History of a transient ischaemic attack iv. Diabetes and currently taking an oral hypoglycemic agent or insulin v. Age ≥70 years vi. History of hypertension vii. Serum creatinine \\>175 µmol/L (\\>2.0 mg/dl) viii. History of smoking within 2 years of surgery ix. Undergoing emergent/urgent surgery\n\nExclusion Criteria:\n\n1. Conduction abnormalities:\n\n A. Non-sinus rhythm on ECG B. Sinoatrial or AV (2nd and 3d degree) blocks C. Sick sinus syndrome D. Long QT syndrome E. Pacemaker dependent\n2. Transplanted heart (or on waiting list)\n3. Use of a selected class I or III antiarrhythmic drug (quinidine, disopyramide, sotalol, ibutilide, amiodarone) or diltiazem/verapamil\n4. Resting heart rate \\<65 beats per minute on the day of surgery\n5. Systolic blood pressure \\<90 mmHg on the day of surgery\n6. Acute decompensated heart failure, cardiogenic shock, acute myocarditis\n7. Acute coronary syndrome within 2 months before surgery;\n8. Stroke or transient cerebral ischaemia within 1 month before surgery\n9. Known severe liver or kidney disease (MDRD creatinine clearance \\<15 mL/min)\n10. Inability to tolerate oral intake\n11. Recent use of ivabradine (\\<1 month)\n12. Known allergy or hypersensitivity to ivabradine\n13. Low-risk surgical procedure based on individual physician's judgment\n14. Investigator considers the patient unreliable regarding requirement for study compliance\n15. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding\n16. Previously enrolled in the PREVENT-MINS study"}, 'identificationModule': {'nctId': 'NCT05279651', 'acronym': 'PREVENT-MINS', 'briefTitle': 'Ivabradine for Prevention of Myocardial Injury After Noncardiac Surgery Trial (PREVENT-MINS)', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Ivabradine for PREVENTion of Myocardial Injury After Noncardiac Surgery', 'orgStudyIdInfo': {'id': 'PREVENT-MINS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ivabradine', 'description': 'Patients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive 5mg of oral ivabradine at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive 5mg oral ivabradine twice a day and continue this treatment for 7 days after surgery or until hospital discharge.', 'interventionNames': ['Drug: Ivabradine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive matching placebo at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive matching placebo twice a day and continue this treatment for 7 days after surgery or until hospital discharge.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ivabradine', 'type': 'DRUG', 'description': 'Patients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive 5mg of oral ivabradine at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive 5mg oral ivabradine twice a day and continue this treatment for 7 days after surgery or until hospital discharge.', 'armGroupLabels': ['Ivabradine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive matching placebo at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive matching placebo twice a day and continue this treatment for 7 days after surgery or until hospital discharge.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-094', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza w Bydgoszczy', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '06-400', 'city': 'Ciechanów', 'country': 'Poland', 'facility': 'Specjalistyczny Szpital Wojewódzki w Ciechanowie', 'geoPoint': {'lat': 52.88141, 'lon': 20.61996}}, {'zip': '43-400', 'city': 'Cieszyn', 'country': 'Poland', 'facility': 'ZZOZ Szpital Śląski w Cieszynie', 'geoPoint': {'lat': 49.75133, 'lon': 18.63213}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne Gdańskiego Uniwersytetu Medycznego', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '26-200', 'city': 'Gmina Końskie', 'country': 'Poland', 'facility': 'Szpital Specjalistyczny św. Łukasza w Końskich', 'geoPoint': {'lat': 51.19166, 'lon': 20.40607}}, {'zip': '40-752', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '30-693', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Szpital św. Rafała w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '30-901', 'city': 'Krakow', 'country': 'Poland', 'facility': '5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-061', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-202', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Krakowski Szpital Specjalistyczny im. Jana Pawła II', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'SP ZOZ Szpital Uniwersytecki w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-826', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o.', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-913', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Szpital Specjalistyczny im. Stefana Żeromskiego w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '92-213', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-081', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny 1 w Lublinie', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '10-561', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Wojewódzki Szpital Specjalistyczny w Olsztynie', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '45-401', 'city': 'Opole', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny w Opolu', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'zip': '70-111', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '72-252', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '33-100', 'city': 'Tarnów', 'country': 'Poland', 'facility': 'Specjalistyczny Szpital im. Edwarda Szczeklika w Tarnowie', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '02-005', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-097', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-141', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-556', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny we Wrocławiu', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': '65-001', 'city': 'Zielona Góra', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze', 'geoPoint': {'lat': 51.93548, 'lon': 15.50643}}], 'overallOfficials': [{'name': 'Wojciech Szczeklik, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Population Health Research Institute', 'class': 'OTHER'}, {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Wojciech Szczeklik MD PhD', 'investigatorFullName': 'Wojciech Szczeklik', 'investigatorAffiliation': 'Jagiellonian University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-19', 'type': 'RELEASE'}, {'date': '2025-12-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Wojciech Szczeklik, Principal Investigator Wojciech Szczeklik MD PhD, Jagiellonian University'}}}}