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Trial record 98 of 1447 for:    Prediction | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03493516
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Lantheus Medical Imaging
Information provided by (Responsible Party):
JOHN CANTY, State University of New York at Buffalo

Brief Summary:
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.

Condition or disease Intervention/treatment
Sudden Cardiac Arrest Ischemic Cardiomyopathy Congestive Heart Failure Diagnostic Test: PET scan quantifying sympathetic denervation using [18F]-LMI1195

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
Estimated Enrollment : 302 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of ARrhythmic Events With Positron Emission Tomography II
Actual Study Start Date : April 8, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: PET scan quantifying sympathetic denervation using [18F]-LMI1195
    A cardiac PET scan will be obtained to quantify the percentage of the left ventricle that is denervated and has reduced uptake of the sympathetic nerve tracer [18F]-LMI1195


Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. All cause cardiac mortality [ Time Frame: Through study completion, an average of 3 years ]
    Adjudicated total cardiac mortality (SCA + non-sudden cardiac death).

  2. 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.

  3. 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.


Biospecimen Retention:   Samples Without DNA
Serum and plasma samples will be obtained for protein biomarkers indicating increased risk of arrhythmias including brain natriuretic peptide levels.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • Coronary artery disease (by cardiac catheterization or definite myocardial infarction)
  • ICD implantation for the primary prevention of SCA
  • Medical therapy including beta-blockers and angiotensin inhibition therapy [angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor antagonist (ARA)].

Exclusion Criteria:

  • Plans for coronary revascularization (due to the independent impact on SCA)
  • Anticipated or active cardiac resynchronization therapy (CRT) (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
  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493516


Contacts
Contact: John M Canty, MD (716) 829-2663 canty@buffalo.edu
Contact: James A Fallavollita, MD (716) 829-2663 jaf7@buffalo.edu

Locations
United States, New York
University at Buffalo Clinical and Translational Research Center Recruiting
Buffalo, New York, United States, 14214
Contact: Eileen Daetsch, NP    716-888-4848    daetsch@buffalo.edu   
Contact: Robin Stein, RN    716 888-4859    rmstein3@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
National Heart, Lung, and Blood Institute (NHLBI)
Lantheus Medical Imaging
Investigators
Principal Investigator: John M Canty, MD University at Buffalo

Publications:
Responsible Party: JOHN CANTY, SUNY Distinguished Professor, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03493516     History of Changes
Other Study ID Numbers: HL-130266
R01HL130266-01 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by JOHN CANTY, State University of New York at Buffalo:
Positron Emission Tomography
Sympathetic Innervation
Sudden Death
Ventricular Fibrillation
LMI-1195
Ischemic Cardiomyopathy
Risk Prediction

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Arrest
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Death
Pathologic Processes