# Pre-DETERMINE: Biologic Markers and MRI SCD Cohort Study

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2020 · $1,327,357

## Abstract

There are an estimated 250,000 sudden cardiac deaths (SCD) annually in the United States constituting
approximately 50% of all cardiac deaths. Although clinical trials have demonstrated convincing survival
benefits conferred by implantable cardioverter defibrillator (ICD) therapy in selected patients with left
ventricular ejection fractions (LVEF) less than 35% and congestive heart failure, the overwhelming majority of
patients who suffer a cardiac arrest will have an LVEF> 0.35. In this competing continuation of the PRE-
DETERMINE: Biologic Markers and MRI SCD Cohort Study, we propose to determine whether biologic
markers and ECGs can be utilized to advance SCD risk prediction in patients with CHD and LVEF>30-35%
where methods for SCD risk prediction are lacking. In the first grant cycle, 5764 patients with CHD and
LVEF>30-35% were enrolled in multicenter prospective cohort study, PREDETERMINE, and blood samples
and ECGs were collected, stored, and a panel of biomarkers, fatty acids, and a multitude of ECG parameters
have been/will be measured. In addition, a wealth of information on demographics, clinical and lifestyle
characteristics, and cardiac test results has been collected and stored. In a subset of patients, contrast-
enhanced cardiac MRIs (CE-MRI) were collected and analyzed for infarct size and other morphologic features.
The cohort has been closely followed centrally by mail and phone for 3 years with low rates of lost to follow-up,
and adjudication of cause specific mortality and arrhythmic events is ongoing. The primary endpoint is a
combined endpoint of sudden and/or arrhythmic death (SAD) and out-of-hospital VF arrest (VF). In the
Competing Continuation, we will leverage this rich and unique resource created during the first grant cycle to
address the following aims regarding SCD risk prediction in this understudied population. 1).To evaluate
whether biomarkers and ECG characteristics can be utilized to identify the presence of high risk
arrhythmogenic myocardial scar on CE-MRI. 2).To determine whether these and other biologic and ECG
markers associated with SCD in the general population are associated with SAD/VF in this population. 3).To
develop clinically useful predictive models based on combinations of biomarkers, ECG characteristics and
conventional risk factors that predict risk of SAD/VF as opposed to other causes of mortality in patients with
CHD who do not have severe systolic dysfunction. 4).To test whether genetic risk scores can add to SAD/VF
risk reclassification in CHD patients who do not have severe systolic dysfunction. If biomarkers, ECG, or
genetic markers are identified that can predict the occurrence of SAD/VF to a greater extent than other causes
of mortality in this population, then these markers may serve as relatively inexpensive methods to identify
patients with CHD and LVEF>30-35% who might benefit from the ICD. The findings may also enhance our
mechanistic understanding of SAD in the setting of CHD, whi...

## Key facts

- **NIH application ID:** 9860930
- **Project number:** 5R01HL091069-09
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** CHRISTINE M ALBERT
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,327,357
- **Award type:** 5
- **Project period:** 2008-09-15 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9860930

## Citation

> US National Institutes of Health, RePORTER application 9860930, Pre-DETERMINE: Biologic Markers and MRI SCD Cohort Study (5R01HL091069-09). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9860930. Licensed CC0.

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