Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-27 @ 11:24 AM
Study NCT ID:
NCT01114269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRE-DETERMINE Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, buffy coat, and red blood cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5764}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2010-04-29', 'studyFirstSubmitQcDate': '2010-04-29', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation.', 'timeFrame': 'Median follow-up estimated to be 10.7 years', 'description': 'A definite sudden cardiac death (SCD) is defined as a death or fatal cardiac arrest occurring within 1 hour of symptom onset or the presence of autopsy consistent with SCD (e.g. acute coronary thrombosis). Probable SCD is defined as an unwitnessed death or death during sleep where the participant was observed to be symptom-free within the preceding 24 hours. Arrhythmic death is defined as the abrupt spontaneous collapse of circulation without antecedent circulatory or neurologic impairment. Deaths classified as non-arrhythmic are not included in the primary endpoint regardless of timing. Resuscitated ventricular fibrillation is defined as out-of-hospital cardiac arrests with documented VF and/or use of external electrical defibrillation for resuscitation.'}], 'secondaryOutcomes': [{'measure': 'ICD Shock', 'timeFrame': 'Median follow-up estimated to be 10.7 years', 'description': 'ICD therapies for ventricular arrhythmias over 200 BPMs will be added to the endpoint.'}, {'measure': 'ICD Implantation', 'timeFrame': 'Median follow-up estimated to be 10.7 years'}, {'measure': 'Total Cardiac Mortality', 'timeFrame': 'Median follow-up estimated to be 10.7 years'}, {'measure': 'Total Mortality', 'timeFrame': 'Median follow-up estimated to be 10.7 years'}, {'measure': 'Non-Sudden or Arrhythmic Causes of Mortality', 'timeFrame': 'Median follow-up estimated to be 10.7 years', 'description': 'Competing causes of mortality in competing risk analyses.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Sudden Cardiac Death', 'Myocardial Infarction', 'Percutaneous Coronary Intervention', 'Implantable Cardiac Defibrillator'], 'conditions': ['Coronary Artery Disease', 'Left Ventricular Dysfunction', 'Sudden Cardiac Death']}, 'referencesModule': {'references': [{'pmid': '6145665', 'type': 'RESULT', 'citation': 'Krieglstein GK, Schrems W. [Stereospecificity of beta-blocker effects on the glaucomatous eye]. Fortschr Ophthalmol. 1984;81(2):127-9. No abstract available. German.'}, {'pmid': '7033860', 'type': 'RESULT', 'citation': 'Friedlander MH, Werblin TP, Kaufman HE, Granet NS. Clinical results of keratophakia and keratomileusis. Ophthalmology. 1981 Aug;88(8):716-20. doi: 10.1016/s0161-6420(81)34957-4.'}, {'pmid': '7263700', 'type': 'RESULT', 'citation': 'Weisgraber KH, Rall SC Jr, Mahley RW. Human E apoprotein heterogeneity. Cysteine-arginine interchanges in the amino acid sequence of the apo-E isoforms. J Biol Chem. 1981 Sep 10;256(17):9077-83. No abstract available.'}, {'pmid': '6981228', 'type': 'RESULT', 'citation': 'Chao FC, Tullis JL, Alper CA, Glynn RJ, Silbert JE. Alteration in plasma proteins and platelet functions with aging and cigarette smoking in healthy men. Thromb Haemost. 1982 Jun 28;47(3):259-64.'}, {'pmid': '36007985', 'type': 'RESULT', 'citation': 'Sandhu RK, Dron JS, Liu Y, Moorthy MV, Chatterjee NA, Ellinor PT, Chasman DI, Cook NR, Khera AV, Albert CM. Polygenic Risk Score Predicts Sudden Death in Patients With Coronary Disease and Preserved Systolic Function. J Am Coll Cardiol. 2022 Aug 30;80(9):873-883. doi: 10.1016/j.jacc.2022.05.049.'}, {'pmid': '39378245', 'type': 'RESULT', 'citation': 'Peek N, Hindricks G, Akbarov A, Tijssen JGP, Jenkins DA, Kapacee Z, Parkes LM, van der Geest RJ, Longato E, Sprague D, Taleb Y, Ong M, Miller CA, Shamloo AS, Albert C, Barthel P, Boveda S, Braunschweig F, Johansen JB, Cook N, de Chillou C, Elders P, Faxen J, Friede T, Fusini L, Gale CP, Jarkovsky J, Jouven X, Junttila J, Kautzner J, Kiviniemi A, Kutyifa V, Leclercq C, Lee DC, Leigh J, Lenarczyk R, Leyva F, Maeng M, Manca A, Marijon E, Marschall U, Merino JL, Mont L, Nielsen JC, Olsen T, Pester J, Pontone G, Roca I, Schmidt G, Schwartz PJ, Sticherling C, Suleiman M, Taborsky M, Tan HL, Tfelt-Hansen J, Thiele H, Tomaselli GF, Verstraelen T, Vinayagamoorthy M, Olesen KKW, Wilde A, Willems R, Wu KC, Zabel M, Martin GP, Dagres N. Sudden cardiac death after myocardial infarction: individual participant data from pooled cohorts. Eur Heart J. 2024 Nov 14;45(43):4616-4626. doi: 10.1093/eurheartj/ehae326.'}, {'pmid': '33124739', 'type': 'RESULT', 'citation': 'Panicker GK, Narula DD, Albert CM, Lee DC, Kothari S, Goldberger JJ, Cook N, Schaechter A, Kim E, Moorthy MV, Pester J, Chatterjee NA, Kadish AH, Karnad DR. Validation of electrocardiographic criteria for identifying left ventricular dysfunction in patients with previous myocardial infarction. Ann Noninvasive Electrocardiol. 2021 Mar;26(2):e12812. doi: 10.1111/anec.12812. Epub 2020 Oct 30.'}, {'pmid': '34332876', 'type': 'RESULT', 'citation': 'Venkateswaran RV, Moorthy MV, Chatterjee NA, Pester J, Kadish AH, Lee DC, Cook NR, Albert CM. Diabetes and Risk of Sudden Death in Coronary Artery Disease Patients Without Severe Systolic Dysfunction. JACC Clin Electrophysiol. 2021 Dec;7(12):1604-1614. doi: 10.1016/j.jacep.2021.05.014. Epub 2021 Jul 28.'}, {'pmid': '32259257', 'type': 'DERIVED', 'citation': 'Chatterjee NA, Tikkanen JT, Panicker GK, Narula D, Lee DC, Kentta T, Junttila JM, Cook NR, Kadish A, Goldberger JJ, Huikuri HV, Albert CM; PREDETERMINE Investigators. Simple electrocardiographic measures improve sudden arrhythmic death prediction in coronary disease. Eur Heart J. 2020 Jun 1;41(21):1988-1999. doi: 10.1093/eurheartj/ehaa177.'}, {'pmid': '28724134', 'type': 'DERIVED', 'citation': 'Adabag S, Patton KK, Buxton AE, Rector TS, Ensrud KE, Vakil K, Levy WC, Poole JE. Association of Implantable Cardioverter Defibrillators With Survival in Patients With and Without Improved Ejection Fraction: Secondary Analysis of the Sudden Cardiac Death in Heart Failure Trial. JAMA Cardiol. 2017 Jul 1;2(7):767-774. doi: 10.1001/jamacardio.2017.1413.'}], 'seeAlsoLinks': [{'url': 'http://www.nlm.nih.gov/medlineplus/cardiacarrest.html', 'label': 'Cardiac Arrest'}, {'url': 'http://www.nlm.nih.gov/medlineplus/coronaryarterydisease.html', 'label': 'Coronary Artery Disease'}, {'url': 'http://www.nlm.nih.gov/medlineplus/pacemakersandimplantabledefibrillators.html', 'label': 'Pacemakers and Implantable Defibrillators'}, {'url': 'http://clinicaltrials.gov/ct2/info/fdalinks', 'label': 'U.S. FDA Resources'}, {'url': 'http://www.nlm.nih.gov/medlineplus/heartdiseases.html', 'label': 'Heart Disease'}, {'url': 'https://www.pre-determinestudy.org', 'label': 'PRE-DETERMINE Study Website'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center cohort study of patients with a history of coronary artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%). The primary objective of this study is to determine whether biologic markers and ECGs can be utilized to advance SCD risk prediction in patients with CHD and LVEF\\>30-35%. The overarching goal of the study is to identify a series of markers that alone or in combination specifically predict risk of arrhythmic death as compared to other causes of mortality among this at risk population of coronary heart disease (CHD) patients with preserved left ventricular ejection fraction (LVEF\\> 30-35%). If biologic or ECG markers are identified that can specifically predict risk of ventricular arrhythmias, then these markers may serve as relatively inexpensive methods to identify those at risk. The public health impact of identifying markers could be quite substantial, leading to more efficient utilization of ICDs and advances in our understanding of mechanisms underlying SCD.', 'detailedDescription': 'The PRE-DETERMINE Study is a prospective, multi-center study of patients with a history of coronary artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%). Patients were enrolled at 135 sites where information on baseline demographics, clinical characteristics, pertinent past medical history, lifestyle habits, cardiac test results, and medications were collected via electronic data capture. Electrocardiograms along with a blood sample was also collected at baseline, sent to central laboratories, and stored for future analyses. Contrast-enhanced magnetic resonance imaging (CE-MRI) scans were collected on a subset of patients and analyzed. Enrollment closed in November 2013 and patients are now being followed centrally by the Clinical Coordinating Center via mail/phone to document interim non-fatal arrhythmic events and cause-specific mortality. Questionnaires that inquire about intervening ICD implantations, ICD therapies, cardiac arrest, and other pertinent cardiovascular endpoints are mailed to participants every six months, and follow-up telephone calls are made to non-responders. Study endpoints are being confirmed through review of medical records, interviews with next-of-kin, and autopsy reports, if available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants have been recruited throughout multicenter sites participating in the PRE-DETERMINE Cohort Study. Patients with a history of coronary artery disease and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%) have been enrolled. The clinical study staff at each site, which was either a research nurse, fellow, or physician approached eligible patients to discuss their potential participation.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial Infarction.\n2. LVEF \\>35% by any current standard evaluation technique (e.g.,) echocardiogram, MUGA, angiography). 2.1. Patients who have an LVEF between 30-35% and NYHA Class I heart failure who do not have history of ventricular tachyarrhythmias,or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled.\n3. If documented prior MI is not present, evidence of mild-moderate systolic Left Ventricular Dysfunction with an EF \\>35- ≤50% as measured by any current standard screening technique (e.g.,echocardiogram, MUGA, angiography) must be present.\n4. Patients aged 18 years or above\n\n 1. CAD will be defined as evidence of one of the following two (2) criteria:\n\n * Significant stenosis of a major epicardial vessel (\\>50% proximal or 70% distal) by coronary angiography\n * Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery)\n 2. MI can be documented in the following ways:\n\n * From the MI hospitalization: Detection of a rise and fall of cardiac biomarkers \\> 99th percentile of lab (e.g., CPK elevation or Troponin at least \\> two times the upper limit of normal) together with myocardial ischemia with at least one of the following:\n\n * Symptoms of Ischemia\n * ECG changes indicative of new ischemia (new ST-T changes or new LBBB)\n * Development of pathological Q waves\n * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality\n * If no report from the MI hospitalization is available, prior MI can be met by either of the following:\n\n * Development of pathological Q waves\n * Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischaemic cause\n\nExclusion Criteria:\n\n1. History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater - the occurrence of cardiac arrest or spontaneous VT in the setting of an acute MI is not considered an exclusion).\n2. Unexplained syncope\n3. Current or planned implantable cardiac defibrillator (ICD)\n4. Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival)\n5. Metastatic cancer\n6. Marked valvular heart disease requiring surgical intervention\n7. Current or planned cardiac, renal or liver transplant\n8. Current alcohol or drug abuse\n9. Unwilling or unable to provide informed consent\n10. LVEF \\<35% with Class II-IV CHF or LVEF \\<30%\n11. Participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties"}, 'identificationModule': {'nctId': 'NCT01114269', 'briefTitle': 'PRE-DETERMINE Cohort Study', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study', 'orgStudyIdInfo': {'id': '2007P000840'}, 'secondaryIdInfos': [{'id': 'R01HL091069', 'link': 'https://reporter.nih.gov/quickSearch/R01HL091069', 'type': 'NIH'}, {'id': 'R01HL165840', 'link': 'https://reporter.nih.gov/quickSearch/R01HL165840', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Heart Institute', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Heart, PLLC', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cardiovascular Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92220', 'city': 'Banning', 'state': 'California', 'country': 'United States', 'facility': 'Beaver Medical Group/Clinical Care Research', 'geoPoint': {'lat': 33.92557, 'lon': -116.87641}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Memorial Health System', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Heart and Vascular', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Area Cardiology Associates, P.A.', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Gainsville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Reliable Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Regional Medical Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33410', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Gardens Research Center', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '34233', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Velella Research', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Research Institute, Inc.', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiology Associates of Palm Beach - West Palm Beach', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30014', 'city': 'Covington', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Heart Specialist', 'geoPoint': {'lat': 33.59678, 'lon': -83.86018}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Heart Center, P.C.', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60643', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Medical Group', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Medical Group - Heart and Vascular of IL', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60160', 'city': 'Melrose Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Consultants in Cardiovascular Medicine', 'geoPoint': {'lat': 41.90059, 'lon': -87.85673}}, {'zip': '46011', 'city': 'Anderson', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Heart and Vascular', 'geoPoint': {'lat': 40.10532, 'lon': -85.68025}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'The University of Kansas', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70363', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Leonard J. 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