Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-25 @ 7:39 AM
Study NCT ID:
NCT02138604
Status:
COMPLETED
Last Update Posted:
2020-07-20
First Post:
2014-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non Invasive dP/dt to Detect an Acute Ischemic Myocardial Dysfunction in Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2014-05-12', 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plethysmographic dP/dt cardiac output value in patients with acute chest pain', 'timeFrame': 'at admission', 'description': 'compare the noninvasive dP/dt values in the two study groups: Acute Coronary syndrome (ACS) and non ACS.\n\nthe diagnostic of ischemic origin of chest pain is based on anamnestic, electrocardiographic, and necrosis enzymes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chest pain', 'myocardial ischemia', 'acute myocardial dysfunction', 'plethesmography', 'non invasive dP/dt'], 'conditions': ['Acute Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': 'Most patients presenting to the emergency department with chest discomfort have a nonischemic ECG and biomarkers of myocardial necrosis within normal limits. These patients are routinely admitted to hospital because of diagnostic uncertainty for occult MI or ischaemia.\n\nAcute myocardial ischemia is associated with acute mycardial dysfunction We tested a non-invasive plethysmographic arterial pressure change index of myocardial performance (dP/dt) that could be added to the diagnostic triage of ischaemia in the ER avoiding unnecessary admissions.', 'detailedDescription': 'For patients with chest pain , the ECG remains the most important initial risk assessment tool. Myocardial ischemia or infarction is highly likely in patients with significant ST segment changes on the ECG or elevation in myocardial markers of necrosis. Identification of high-risk patients is more difficult in those with non ischemic ECG and negative markers on presentation.\n\nOne of the most sensitive indices of contractility is the rate of increase of intraventricular pressure during isovolumetric contraction, (left ventricular dP/dt and arterial dP/dt). Dp/dt (dP/dt ejc ) represents the rate of change of pressure during ejection. It has been shown that cardiac contractility and dP/dt decreases during acute myocardial ischemia.\n\nWe theorized that a higher value of dP/dt would be found for non ischemic chest pain than during ischemic chest pain because ischemia reduces myocardial contractility, whereas chest pain of non cardiac origin increases dP/dt by the stress of the pain itself.\n\nThe current study describes a noninvasive plethysmographic dP/dt changes in patients presenting at the emergency department with acute chest pain, which could be added to the diagnostic triage of ischemia in the ED, thus decreasing the number of unnecessary admissions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the emergency department with acute chest pain', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 year old\n* Chest pain that lasted less than 12 hours\n\nExclusion Criteria:\n\n* traumatic chest pain\n* arrythmias\n* STEMI'}, 'identificationModule': {'nctId': 'NCT02138604', 'acronym': 'dP/dtAMDED', 'briefTitle': 'Non Invasive dP/dt to Detect an Acute Ischemic Myocardial Dysfunction in Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Non Invasive dP/dt is Not a Good Index to Detect an Acute Ischemic Myocardial Dysfunction in Emergency Department (ED)', 'orgStudyIdInfo': {'id': 'dp/dt to detect AMD in ED'}}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'state': 'CHU Fattouma Bourguiba', 'country': 'Tunisia', 'facility': 'Nouira Semir', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'semir Nouira, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Non invasive dP/dt is not a good index to detect an acute ischemic myocardial dysfunction in emergency department (ED)', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}