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PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study

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Trial Conditions
  • Coronary Artery Disease
  • Left Ventricular Dysfunction
  • Sudden Cardiac Death
What is the purpose of this trial?

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 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> 35%). In addition, we will also address whether these promising genetic markers and biomarkers advance sudden cardiac death (SCD) risk prediction when combined with advanced substrate imaging by participants that have undergone a CE-MRI at baseline.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria

1. Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial
Infarction.

2. 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.

3. 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.

4. Patients aged 18 years or above

4.1. CAD will be defined as evidence of one of the following two(2)criteria:

1. Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by
coronary angiography

2. Prior revascularization (percutaneous coronary intervention or coronary artery bypass
surgery)

4.2. MI can be documented in the following ways:

1. 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:

- Symptoms of Ischemia

- ECG changes indicative of new ischemia (new ST-T changes or new LBBB)

- Development of pathological Q waves

- Imaging evidence of new loss of viable myocardium or new regional wall motion
abnormality

2. If no report from the MI hospitalization is available, prior MI can be met by either
of the following:

- Development of pathological Q waves

- 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

Exclusion Criteria

1. 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).

2. Unexplained syncope

3. Current or planned implantable cardiac defibrillator (ICD)

4. Any condition other than cardiac disease that, in the investigator's judgment, would
seriously limit life expectancy (poor survival)

5. Metastatic cancer

6. Marked valvular heart disease requiring surgical intervention

7. Current or planned cardiac, renal or liver transplant

8. Current alcohol or drug abuse

9. Unwilling or unable to provide informed consent

10. LVEF <35% with Class II-III CHF or LVEF <30%

11. Participation in a clinical trial where the active treatment arm is testing an agent
and/or intervention with known antiarrhythmic properties

Gender: Both
Steward Physician(s)
  • Christine M Albert, MD, MPH
Facilities
  • St. Elizabeth's Medical Center - Recruiting
Physician Researcher

Investigator Name:

  • Christine M Albert, MD, MPH

Other Information

Sponsor: Brigham and Women's Hospital
Phase: N/A
Trial ID: NCT01114269
Volunteers:  Not Accepting Healthy Volunteers

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