Prediction of ARrhythmic Events With Positron Emission Tomography II (PAREPET II)

January 31, 2024 updated by: JOHN CANTY, State University of New York at Buffalo
Sudden cardiac death continues to be a major contributor to mortality in patients with ischemic cardiomyopathy. While implantable defibrillators can prevent death from ventricular arrhythmias, our current approach to identify patients at highest risk primarily rests on demonstrating a reduction in left ventricular ejection fraction less than 35%. The purpose of this observational cohort study is to prospectively test whether this can be enhanced by quantifying the amount of sympathetic denervation, left ventricular end-diastolic volume or brain natriuretic peptide levels.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Using current guidelines based primarily on ejection fraction (EF), only one-quarter of patients receiving an implantable cardiac defibrillator (ICD) for the primary prevention of sudden cardiac arrest (SCA) require appropriate ICD therapy within 5 years. The NIH-sponsored PAREPET study (Prediction of ARrhythmic Events with Positron Emission Tomography, ClinicalTrials.gov, NCT01400334) identified four independent risk factors that predict SCA or ICD equivalent in patients with ischemic cardiomyopathy. Using retrospectively defined cut-points, the absence of these risk factors identified 38% of the cohort with a very low risk of SCA (<1% per year). This rate is actually lower than the 1.5-2% annual rate of SCA among patients with coronary artery disease and mild left ventricular (LV) dysfunction, who are not considered candidates for a primary prevention ICD. This proposal will prospectively determine whether these risk factors can form the basis of a clinically applicable approach to identify a subgroup of patients who are candidates for an ICD, but are at low enough risk of SCA to have an ICD safely withheld. Our long-term goal is to develop better approaches to identify patients with coronary artery disease who are most likely to benefit from prevention of SCA with placement of an implantable defibrillator.

Study Type

Observational

Enrollment (Estimated)

302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • University at Buffalo Clinical and Translational Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population comprises adult patients of either sex with ischemic cardiomyopathy who have an ejection fraction ≤ 35% and New York Heart Association Class II or III CHF or an ejection fraction ≤ 30% and Class I CHF who are candidates to place an ICD for the primary prevention of SCA. Subjects already having a primary prevention ICD are eligible if they have not yet received an appropriate ICD shock for ventricular arrhythmias.

Description

Inclusion Criteria:

  • Coronary artery disease (by cardiac catheterization or definite myocardial infarction)
  • ICD implantation for the primary prevention of SCA

  • Primary prevention patients with a Biventricular ICD

    • Eligible immediately when this is placed to prevent dysynchrony related to intermittent RV pacing and the native QRS duration is ≤ 130 msec in the absence of pacing.
    • Eligible 6 months after implantation when the native QRS duration prior to implant is >130 msec or there is persistent RV pacing.
  • Optimal medical therapy for heart failure.

Exclusion Criteria:

  • Plans for coronary revascularization (due to the independent impact on SCA)
  • Contraindication for PET (i.e. claustrophobia, pregnancy, physical limitation)
  • Tricyclic antidepressant use (inhibits norepinephrine and LMI1195 uptake)
  • Comorbidities limiting life expectancy <2yr.
  • Age <18 years or inability to provide informed consent
  • Primary prevention ICD/BiV recipients who have received an appropriate ICD shock prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sudden Cardiac Arrest Events
Time Frame: Through study completion, an average of 3 years
The primary end-point will be SCA or ICD equivalent as used in PAREPET. This will consist of ICD therapies for ventricular fibrillation or ventricular tachycardia >240 bpm, and adjudicated arrhythmic death using the modified Hinkle-Thaler criteria.
Through study completion, an average of 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause cardiac mortality
Time Frame: Through study completion, an average of 3 years
Adjudicated total cardiac mortality (SCA + non-sudden cardiac death).
Through study completion, an average of 3 years
All appropriate ICD therapies
Time Frame: Through study completion, an average of 3 years
Adjudicated appropriate ICD therapies (ICD shock and anti-tachycardia pacing) for ventricular arrhythmias. Appropriate ICD therapies will be determined from ICD device interrogation.
Through study completion, an average of 3 years
Hospitalization for heart failure and myocardial infarction.
Time Frame: Through study completion, an average of 3 years
Interval hospitalizations for heart failure or myocardial infarction will be assessed via phone follow-up at 3 month intervals. Subjects having either will be invited to return for a repeat PET scan, echocardiogram and serum sampling to assess whether the underlying substrate for arrhythmogenesis has changed.
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Lantheus Medical Imaging

Investigators

  • Principal Investigator: John M Canty, MD, University at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2018

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL-130266
  • R01HL130266-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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