Ignite Creation Date:
2024-05-05 @ 10:28 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01114269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-10
First Post:
2010-04-29
Brief Title:
PRE-DETERMINE Cohort Study
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
PRE-DETERMINE Biologic Markers and MRI SCD Cohort Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 LVEF30-35 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
Detailed Description:
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 mailphone 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL091069 | NIH | None | httpsreporternihgovquickSearchR01HL091069 |