NCT01400334

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

8.4 years

First QC Date

July 20, 2011

Last Update Submit

October 8, 2020

Conditions

Ischemic CardiomyopathyHibernating MyocardiumNerve; Disorder, Sympathetic

Keywords

Ischemic CardiomyopathySudden Cardiac DeathPositron Emission TomographyHibernating MyocardiumDenervated Myocardium

Outcome Measures

Primary Outcomes (1)

  • Sudden Cardiac Death

    Adjudicated sudden cardiac death and implantable cardiac defibrillator therapy for fast ventricular tachycardia (\>240 bpm) or ventricular fibrillation.

    every 3 months

Secondary Outcomes (1)

  • Cardiac Death

    every 3 months

Study Arms (1)

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.

Radiation: Positron Emission Tomography

Interventions

Positron Emission TomographyRADIATION

Quantification of cardiac function using positron emission tomography and: a)11C-meta-hydroxyephedrine \[HED, 20 mCi (740 MBq)\] to quantify sympathetic nerve function, b) 13N-ammonia \[NH3, 20 mCi (740 MBq)\] for regional perfusion, and c) 18F-2-deoxyglucose \[FDG; 6.5 mCi (241 MBq)\] administered during a hyperinsulinemic-euglycemic clamp to assess viability.

Ischemic Cardiomyopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNYBuffalo

Buffalo, New York, 14214, United States

Location

Related Publications (7)

  • Fallavollita JA, Luisi AJ Jr, Michalek SM, Valverde AM, deKemp RA, Haka MS, Hutson AD, Canty JM Jr. Prediction of arrhythmic events with positron emission tomography: PAREPET study design and methods. Contemp Clin Trials. 2006 Aug;27(4):374-88. doi: 10.1016/j.cct.2006.03.005. Epub 2006 May 2.

    PMID: 16647885BACKGROUND

  • Fallavollita JA, Heavey BM, Luisi AJ Jr, Michalek SM, Baldwa S, Mashtare TL Jr, Hutson AD, Dekemp RA, Haka MS, Sajjad M, Cimato TR, Curtis AB, Cain ME, Canty JM Jr. Regional myocardial sympathetic denervation predicts the risk of sudden cardiac arrest in ischemic cardiomyopathy. J Am Coll Cardiol. 2014 Jan 21;63(2):141-9. doi: 10.1016/j.jacc.2013.07.096. Epub 2013 Sep 25.

    PMID: 24076296RESULT

  • Al-Zaiti SS, Fallavollita JA, Canty JM Jr, Carey MG. Electrocardiographic predictors of sudden and non-sudden cardiac death in patients with ischemic cardiomyopathy. Heart Lung. 2014 Nov-Dec;43(6):527-33. doi: 10.1016/j.hrtlng.2014.05.008. Epub 2014 Jul 2.

    PMID: 24996250RESULT

  • Al-Zaiti SS, Fallavollita JA, Wu YW, Tomita MR, Carey MG. Electrocardiogram-based predictors of clinical outcomes: a meta-analysis of the prognostic value of ventricular repolarization. Heart Lung. 2014 Nov-Dec;43(6):516-26. doi: 10.1016/j.hrtlng.2014.05.004. Epub 2014 Jun 29.

    PMID: 24988910RESULT

  • Zelt JGE, Wang JZ, Mielniczuk LM, Beanlands RSB, Fallavollita JA, Canty JM Jr, deKemp RA. Positron Emission Tomography Imaging of Regional Versus Global Myocardial Sympathetic Activity to Improve Risk Stratification in Patients With Ischemic Cardiomyopathy. Circ Cardiovasc Imaging. 2021 Jun;14(6):e012549. doi: 10.1161/CIRCIMAGING.121.012549. Epub 2021 Jun 9.

    PMID: 34102857DERIVED

  • Fallavollita JA, Dare JD, Carter RL, Baldwa S, Canty JM Jr. Denervated Myocardium Is Preferentially Associated With Sudden Cardiac Arrest in Ischemic Cardiomyopathy: A Pilot Competing Risks Analysis of Cause-Specific Mortality. Circ Cardiovasc Imaging. 2017 Aug;10(8):e006446. doi: 10.1161/CIRCIMAGING.117.006446.

    PMID: 28794139DERIVED

  • Cain ME. Impact of denervated myocardium on improving risk stratification for sudden cardiac death. Trans Am Clin Climatol Assoc. 2014;125:141-53; discussion 153.

    PMID: 25125727DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Death, Sudden, Cardiac

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • John M Canty, MD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

  • James A Fallavollita, MD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2011

First Posted

July 22, 2011

Study Start

July 1, 2004

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 12, 2020

Record last verified: 2020-10

Locations

US(1)