Simultaneous Assessment of FFR and SPECT

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02749045
• Other study ID #: PRO15090404
• Status: Terminated
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2021

Study information

• Verified date: January 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Radiation:
• SPECT imaging
myocardial perfusion imaging

Locations

Country	Name	City	State
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Prem Soman	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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