Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-04 @ 11:53 AM
Study NCT ID:
NCT03203057
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2017-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induced Myocardial Ischemia: a Serial Troponin T and Troponin I Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum and plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-20', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-28', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Troponin release', 'timeFrame': '6 hours', 'description': 'Quantifying troponin T and I release after ischemic event'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome', 'Cardiac Ischemia']}, 'referencesModule': {'references': [{'pmid': '33297742', 'type': 'DERIVED', 'citation': 'Arnadottir A, Pedersen S, Bo Hasselbalch R, Goetze JP, Friis-Hansen LJ, Bloch-Munster AM, Skov Jensen J, Bundgaard H, Iversen K. Temporal Release of High-Sensitivity Cardiac Troponin T and I and Copeptin After Brief Induced Coronary Artery Balloon Occlusion in Humans. Circulation. 2021 Mar 16;143(11):1095-1104. doi: 10.1161/CIRCULATIONAHA.120.046574. Epub 2020 Dec 10.'}]}, 'descriptionModule': {'briefSummary': "Background Troponin are proteins found in the cardiomyocyte and are a cornerstone in the diagnoses of acute myocardial infarction. Troponin is released to the bloodstream as a result of an cardiomyocyte injury. Troponin is frequently assessed in hospital care for patients with chest pain and dyspnea.\n\nGuidelines recommend troponin assessment at admission and repeated at 3 to 6 hours, depending on the assay. High-sensitivity assays measure concentrations that are ten-times lower than earlier generations of assays. However, the time from when troponin is elevated in the bloodstream after an ischemic injury, measured with high-sensitivity assays, are not fully known.\n\nDuring an X-ray imaging of the heart's blood vessels (coronary angiogram) it is possible to do a short, controlled occlusion of coronary artery by inflating a small balloon in one of the coronary arteries. Numerous earlier studies in patients have used this method for induced occlusion of one coronary artery for 1 to 3 minutes. Only one of the studies measured troponin I.\n\nThe aim with this study is to quantify and compare the release of troponin T and troponin I in the early hours after a controlled induced ischemia.\n\nStudy Design This is a prospective, descriptive and experimental study. There will be included 40 patients, without acute ischemic cardiac disease. They will be randomized in 4 groups.\n\n0: 10 patients - control group, no balloon occlusion\n\n1. 10 patients - balloon occlusion for 30 seconds\n2. 10 patients - balloon occlusion for 60 seconds\n3. 10 patients - balloon occlusion for 90 seconds\n\nSubsequently there will be assessed serial blood samples 0 - 3 hours: Every 15 minutes 3 - 6 hours: Every 30 minutes\n\nStatistics This is a pilot study and it is estimated that ten patients are sufficient number of patients in each group to assess elevation of troponin after occlusion of coronary artery. The thesis is there is a dosage-response correlation between the length of balloon occlusion and the concentration of troponin in blood stream."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient referred to coronary angiography due to suspicion of ischemic heart disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years of age Elective coronary angiogram Informed signed accept\n\nExclusion Criteria:\n\n* Stenosis or atherosclerosis of the coronary artery Renal Failure or p-creatinin \\> 100 µmol/L Heart Failure or LVEF \\< 50 Severe Heart Valve Disease'}, 'identificationModule': {'nctId': 'NCT03203057', 'acronym': 'ICE-land', 'briefTitle': 'Induced Myocardial Ischemia: a Serial Troponin T and Troponin I Measurements', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Serial Measurements of High-sensitivity Cardiac Troponin T and Troponin I After Short, Controlled Induced Cardiac Ischemia', 'orgStudyIdInfo': {'id': 'H-16027749'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group', 'description': '10 individuals get randomised to control group.'}, {'label': 'short ischemic time', 'description': '10 individuals get randomised to a controlled coronary occlusion for 30 seconds', 'interventionNames': ['Other: coronary occlusion']}, {'label': 'intermediate ischemic time', 'description': '10 individuals get randomised to a controlled coronary occlusion for 60 seconds', 'interventionNames': ['Other: coronary occlusion']}, {'label': 'long ischemic time', 'description': '10 individuals get randomised to a controlled coronary occlusion for 90 seconds', 'interventionNames': ['Other: coronary occlusion']}], 'interventions': [{'name': 'coronary occlusion', 'type': 'OTHER', 'description': 'percutaneous coronary intervention', 'armGroupLabels': ['intermediate ischemic time', 'long ischemic time', 'short ischemic time']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Herlev-Gentofte Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Asthildur Arnadottir', 'investigatorAffiliation': 'Herlev Hospital'}}}}