Simultaneous Assessment of FFR and SPECT

NCT02749045 | Terminated Results DMC

• 1 other identifier: PRO15090404
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this research study is to identify the disparity in ischemia measurement between fractional flow reserve (FFR) used in the cardiac catheterization laboratory and myocardial perfusion stress- single-photon emission computed tomography (SPECT). This study aims to determine the correlation between simultaneous FFR and SPECT obtained using regadenoson in the catheterization laboratory.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Concordance Between Gated SPECT Perfusion Data (QGS) and Fractional Flow Reserve (FFR)

  The concordance will be calculated as the percentage of patients who had an abnormal FFR (\<0.8) and an abnormal SPECT (a perfusion defect on the SPECT) PLUS patients who had a normal FFR (≥ 0.8) and a normal SPECT. concordance= patients with abnormal FFR and abnormal SPECT + patients with normal FFR and normal SPECT/ total no. of patients

  24 hours

Study Arms (1)

Image acquisition arm

OTHER

Subjects who have undergone a clinically indicated fractional flow reserve measurement in the cardiac catheterization laboratory will receive standard dose Tc-99m sestamibi and undergo resting SPECT image acquisition within three hours from end of cardiac catheterization procedure.

Radiation: SPECT imaging

Interventions

SPECT imaging RADIATION

myocardial perfusion imaging

Image acquisition arm

Eligibility Criteria

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

You may qualify if:

• Patients undergoing clinically-indicated FFR measurement (to determine the hemodynamic significance of intermediate degrees of stenosis) for single or two -vessel epicardial coronary disease during diagnostic coronary angiography for suspected coronary artery disease.

You may not qualify if:

• Patients with 3-vessel disease
• Prior coronary artery bypass grafting
• Patients with second or third- degree atrioventricular block, without a functioning pacemaker
• Patients who have ingested caffeine-containing products within the past 12 hours.

Sponsors & Collaborators

• Prem Soman: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

The study was significantly under-recruited. A pre-hoc power calculation indicated that a minimum of 50 patients was required to produce meaningful results. Recruitment was affected by: 1) the increasing use of iFR in place of FFR in the cath lab, and 2) COVID-19.

Results Point of Contact

• Title: Prem Soman, MD, PhD
• Organization: University of Pittsburgh Medical Center

somanp@upmc.edu

412 647 3435

Study Officials

• Prem Soman, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 22, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: February 2, 2022
• Results First Posted: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)