Prediction of ARrhythmic Events With Positron Emission Tomography II

NCT03493516 | Active Not Recruiting DMC FDA Drug

• 2 other identifiers: HL-130266R01HL130266-01
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cardiomyopathy; Congestive Heart Failure; Sudden Cardiac Arrest

Keywords

Positron Emission Tomography; Sympathetic Innervation; Sudden Death; Ventricular Fibrillation; LMI-1195; Ischemic Cardiomyopathy; Risk Prediction

Outcome Measures

Primary Outcomes (1)

• Sudden Cardiac Arrest Events

  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 Outcomes (3)

• All cause cardiac mortality

  Through study completion, an average of 3 years

• All appropriate ICD therapies

  Through study completion, an average of 3 years

• Hospitalization for heart failure and myocardial infarction.

  Through study completion, an average of 3 years

Interventions

PET scan quantifying sympathetic denervation using [18F]-LMI1195 DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Lantheus Medical Imaging: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University at Buffalo Clinical and Translational Research Center

Buffalo, New York, 14214, United States

Location

Related Publications (4)

• 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: 28794139 BACKGROUND

• Malhotra S, Canty JM Jr. Life-Threatening Ventricular Arrhythmias: Current Role of Imaging in Diagnosis and Risk Assessment. J Nucl Cardiol. 2016 Dec;23(6):1322-1334. doi: 10.1007/s12350-015-0392-0. Epub 2016 Jan 15.

  PMID: 26780530 BACKGROUND

• Goldberger JJ, Basu A, Boineau R, Buxton AE, Cain ME, Canty JM Jr, Chen PS, Chugh SS, Costantini O, Exner DV, Kadish AH, Lee B, Lloyd-Jones D, Moss AJ, Myerburg RJ, Olgin JE, Passman R, Stevenson WG, Tomaselli GF, Zareba W, Zipes DP, Zoloth L. Risk stratification for sudden cardiac death: a plan for the future. Circulation. 2014 Jan 28;129(4):516-26. doi: 10.1161/CIRCULATIONAHA.113.007149. No abstract available.

  PMID: 24470473 BACKGROUND

• 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: 24076296 BACKGROUND

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.

MeSH Terms

Conditions

Death, Sudden, Cardiac; Heart Failure; Death, Sudden; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac

Study Officials

• John M Canty, MD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SUNY Distinguished Professor

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 10, 2018
• Study Start: April 8, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)