PRE-DETERMINE Cohort Study
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|ClinicalTrials.gov Identifier: NCT01114269|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2010
Last Update Posted : May 17, 2018
|Condition or disease|
|Coronary Artery Disease Left Ventricular Dysfunction Sudden Cardiac Death|
|Study Type :||Observational|
|Actual Enrollment :||5764 participants|
|Official Title:||PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
- Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation. [ Time Frame: Median follow-up estimated to be 8 years ]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.
- ICD Shock [ Time Frame: Median follow-up estimated to be 8 years ]ICD therapies for ventricular arrhythmias over 200 BPMs will be added to the endpoint.
- ICD Implantation [ Time Frame: Median follow-up estimated to be 8 years ]
- Total Cardiac Mortality [ Time Frame: Median follow-up estimated to be 8 years ]
- Total Mortality [ Time Frame: Median follow-up estimated to be 8 years ]
- Non-Sudden or Arrhythmic Causes of Mortality [ Time Frame: Median follow-up estimated to be 8 years ]Competing causes of mortality in competing risk analyses.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114269
Show 90 Study Locations
|Principal Investigator:||Christine M Albert, M.D., M.P.H.||Brigham and Women's Hospital|