Prediction of ARrhythmic Events With Positron Emission Tomography (PAREPET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by State University of New York at Buffalo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01400334
First received: July 20, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

The hypothesis of PAREPET is that hibernating myocardium (viable myocardium with reduced resting flow) and/or viable but denervated myocardium can predict the risk of sudden death in subjects with ischemic cardiomyopathy.


Condition Intervention
Ischemic Cardiomyopathy
Hibernating Myocardium
Nerve; Disorder, Sympathetic
Other: Positron Emission Tomography (PET)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hibernating Myocardium and Sudden Cardiac Death

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • Sudden Cardiac Death [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
    Adjudicated sudden cardiac death and implantable cardiac defibrillator therapy for fast ventricular tachycardia (>240 bpm) or ventricular fibrillation.


Secondary Outcome Measures:
  • Cardiac Death [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
    Sudden cardiac death and adjudicated non-sudden cardiac death


Biospecimen Retention:   Samples Without DNA

serum and plasma


Enrollment: 257
Study Start Date: July 2004
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ischemic Cardiomyopathy
Subjects with ischemic cardiomyopathy [pre-enrollment left ventricular ejection fraction ≤0.35, with coronary artery disease documented by cardiac catheterization, a history of definite myocardial infarction, or reversible ischemia on nuclear imaging] who are considered eligible to receive an implantable cardiac defibrillator for the primary prevention of sudden cardiac death.
Other: Positron Emission Tomography (PET)
PET scanning with: a) the sympathetic nerve norepinephrine uptake tracer 11C-meta-hydroxyephedrine [HED, 20 mCi (740 MBq)], b) the blood flow tracer 13N-ammonia [NH3, 20 mCi (740 MBq)], and c) the metabolic viability tracer 18F-2-deoxyglucose [FDG; 6.5 mCi (241 MBq)] which was administered after establishing a hyperinsulinemic-euglycemic clamp.

Detailed Description:

Currently available electrophysiological approaches are limited in their ability to identify the majority of patients with CAD and LV dysfunction that succumb to sudden cardiac death (SCD). Half of the patients developing SCD are not inducible at electrophysiological testing underscoring the need for new ways to identify substrates leading to arrhythmic death. Viable chronically dysfunctional with reduced resting flow, or hibernating myocardium, not amenable to revascularization appears to be a major risk factor for subsequent cardiac death and is present in up to 60% of patients with ischemic cardiomyopathy. Cause specific mortality data is limited but appears to be arrhythmic rather than from fatal myocardial infarction or progressive heart failure. Revascularization improves survival but most patients with hibernating myocardium are managed medically due to prohibitive procedural risks or technical limitations. Basic studies in swine with hibernating myocardium demonstrate SCD arising from VT/VF in the absence of myocardial scar or heart failure. The central hypothesis of this proposal is that the presence of hibernating myocardium as opposed to scar identifies a large subset of patients with ischemic cardiomyopathy that are at high risk for SCD. We further hypothesize that this risk is related to inhomogeneity in sympathetic innervation arising from chronic repetitive ischemia. PAREPET is a prospective observational study that will enroll patients with coronary disease, Class I-III heart failure and an ejection fraction ≤35%. Using positron emission tomography (PET), the frequency and amount of hibernating myocardium will be quantified in patients that are not candidates for coronary revascularization. Three Specific Aims are proposed. Aim 1 will determine whether imaging the mismatch between viability (preserved 18F-2-deoxyglucose) and reduced resting flow (13NH3) can predict an increased risk of SCD (or ICD discharge for VT/VF as a surrogate end-point) in hibernating myocardium. Aim 2 will image norepinephrine uptake using 11C-hydroxyephedrine to determine whether inhomogeneity in myocardial sympathetic innervation predicts SCD risk better than viability testing. Aim 3 will identify whether the substrate identified by PET is stable after an aborted SCD event by evaluating temporal changes in function, viability and sympathetic innervation in patients with an ICD. Our long-term objective is to develop better approaches to identify patients with CAD who are most likely to benefit from primary prevention of SCD with placement an ICD.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Residents of Western New York referred for an implantable cardiac defibrillator, transthoracic echocardiography, and/or coronary angiography

Criteria

Inclusion Criteria:

  • LV EF ≤35% (by nuclear imaging, cardiac catheterization or echocardiography)
  • Coronary artery disease documented by cardiac catheterization, a history of definite myocardial infarction, or reversible ischemia on nuclear imaging
  • New York State Heart Association functional Class I-III heart failure
  • Not a candidate for surgical or percutaneous coronary revascularization at the time of enrollment

Exclusion Criteria:

  • History of resuscitated sudden cardiac death, sustained ventricular tachycardia, appropriate implantable cardiac defibrillator (ICD) discharge, or unexplained syncope
  • Myocardial infarction within 30 days
  • Coronary artery bypass grafting within 1 year
  • Percutaneous intervention within 3 months
  • Claustrophobia or physical limitation that would preclude PET scanning
  • Pregnancy
  • Tricyclic antidepressant drug therapy
  • Comorbidities that would be expected to result in noncardiac death within 2 years
  • Inability to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400334

Locations
United States, New York
SUNYBuffalo
Buffalo, New York, United States, 14214
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: John M Canty, MD State University of New York at Buffalo
Principal Investigator: James A Fallavollita, MD State University of New York at Buffalo
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John M. Canty, Jr., MD, SUNYBuffalo
ClinicalTrials.gov Identifier: NCT01400334     History of Changes
Other Study ID Numbers: HL76252
Study First Received: July 20, 2011
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by State University of New York at Buffalo:
Ischemic Cardiomyopathy
Sudden Cardiac Death
Positron Emission Tomography
Hibernating Myocardium
Denervated Myocardium

Additional relevant MeSH terms:
Ischemia
Death, Sudden, Cardiac
Death
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Cardiomyopathies
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 26, 2014