Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-01-10 @ 2:04 PM
Study NCT ID:
NCT02810561
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2016-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Troponin Leaks in Emergency Department Patients Presenting With Supraventricular Tachycardia (SVT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013617', 'term': 'Tachycardia, Supraventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Troponin-I Level', 'timeFrame': '6 hours after initial EKG', 'description': 'Measured in ng/ml'}], 'secondaryOutcomes': [{'measure': 'Death/ Need for Cardiac Stent Placement or Coronary Bypass Artery Graft', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Troponin'], 'conditions': ['Supraventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is twofold. First the investigators would like to determine the trajectory of troponin leaks; if it can be shown that the participants who have only minimal elevations of their repeat troponin universally decrease on the 3rd level then future patients may see significantly improved length of stay. Second, given conflicting results in the literature, the investigators would like to determine if elevated troponin levels correlate to later cardiovascular complications. These complications will be defined as Death, Myocardial Infarction, Cardiovascular intervention (such as coronary artery stenting or bypass). As the investigator is a single hospital system in this county it is uniquely positioned to be able to review this retrospectively.', 'detailedDescription': 'The investigators therefore propose retrospectively studying participants diagnosed with Supraventricular Tachycardia who had troponin(s) checked in the ED between January 1, 2012 and May 31, 2016 to allow a minimum of a year follow-up for our combined endpoint. The investigators will record the participants troponin value(s) in addition to the age, sex, race, heart rate, creatinine value. The investigators will compare the participants with positive troponins (and hopefully participants with strongly positive troponins) with those who are negative for troponin for presence of the combined end point via chart review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting to the Emergency Department with Supraventricular Tachycardia and elevated troponin. All sexs, races and ages will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Supraventricular Tachycardia with troponin elevation\n\nExclusion Criteria:\n\n* Other cardiac arrhythmias or conditions with increased troponin'}, 'identificationModule': {'nctId': 'NCT02810561', 'briefTitle': 'Troponin Leaks in Emergency Department Patients Presenting With Supraventricular Tachycardia (SVT)', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health South'}, 'officialTitle': 'Time Course and the Significance of Troponin Leaks in Emergency Department Patients Presenting With Supraventricular Tachycardia (SVT)', 'orgStudyIdInfo': {'id': 'LH01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'No intervention was completed with this study.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Matthew Hysell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lakeland Health Emergency Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health South', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}