Simultaneous Assessment of FFR and SPECT

January 4, 2022 updated by: Prem Soman

The Simultaneous Assessment of Invasive Fractional Flow Reserve and SPECT Myocardial Ischemia Using Regadenoson in the Catheterization Laboratory

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients who are previously scheduled for diagnostic coronary angiography will be approached for consent to be part of the study. If the patient is found to have one or two vessel disease and it is planned by the interventional cardiologist that FFR will be used, then the previously consented patient will be deemed appropriate for the study. The standard procedure will be followed for FFR testing using regadenoson. The patient will then receive the standard dose of Tc-99m sestamibi. The interventional cardiologist will proceed with percutaneous coronary intervention (PCI) if appropriate. Patients will proceed to the cardiac catheterization laboratory holding area post procedure. Patients will then be scheduled to be taken to the nuclear cardiology laboratory one to three hours following the coronary angiogram for standard SPECT acquisition. Patients will be monitored for 2-6 hours or overnight as clinically indicated following diagnostic coronary angiography and PCI. Low dose resting myocardial perfusion scanning may be performed the next day if stress myocardial perfusion study was abnormal.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Image acquisition arm
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
myocardial perfusion imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance Between Gated SPECT Perfusion Data (QGS) and Fractional Flow Reserve (FFR)
Time Frame: 24 hours

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

Collaborators and Investigators

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

Sponsor

Prem Soman

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Principal Investigator: Prem Soman, MD, University of Pittsburgh Medical Center

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

July 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO15090404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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