CFR-OR: Coronary Flow Reserve (CFR) in Cardiovascular Risk Stratification

Sponsor

Centre Hospitalier Régional d'Orléans (Other)

Overall Status

Completed

CT.gov ID

NCT03586492

Collaborator

(none)

137

Enrollment

Locations

Arm

Actual Duration (Months)

68.5

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CFR has been studied for few years using 82 Rubidium PET (positron emission tomography) /CT. CFR has shown to be correlated with cardiovascular events occurring in the 10 following years. CFR also helps to identify multivessel coronary disease. Few studies have shown the possibility to calculate CFR during myocardial perfusion SPECT on new ultrafast CZT cameras.

Condition or Disease	Intervention/Treatment	Phase
Ischemia, Myocardial Ischemic Heart Disease	Diagnostic Test: CZT SPECT acquisition	N/A

Detailed Description

Evaluate the contribution of CZT SPECT CFR in cardiovascular risk stratification: correlation with clinical scores, with calcium score, and when pathological with coronarography findings especially fractional flow reserve (FFR).

Study Design

Study Type:

Interventional

Actual Enrollment :

137 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

SPECT Myocardial Perfusion Reserve Using a Cadmium Zinc Telluride (CZT) Camera in Cardiovascular Risk Stratification and Ischemia

Actual Study Start Date :

Nov 5, 2018

Actual Primary Completion Date :

Nov 5, 2020

Actual Study Completion Date :

Nov 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Patient with myocardial ischemia	Diagnostic Test: CZT SPECT acquisition CZT SPECT acquisition, with dynamic stress and rest acquisitions to calculate CFR If pathological, coronarography with FFR measurement if necessary In case of intermediate coronary stenosis with medical treatment, SPECT CFR evaluation after one year of treatment

Arm

Intervention/Treatment

Other: Patient with myocardial ischemia

Diagnostic Test: CZT SPECT acquisition

CZT SPECT acquisition, with dynamic stress and rest acquisitions to calculate CFR If pathological, coronarography with FFR measurement if necessary In case of intermediate coronary stenosis with medical treatment, SPECT CFR evaluation after one year of treatment

Outcome Measures

Primary Outcome Measures

Regional and global CFR [Day 0]
Regional and global CFR calculated from CZT SPECT myocardial perfusion: correlation with clinical score and calcium score

Secondary Outcome Measures

FFR Regional CFR after one year of medical treatment [Up to one year]
FFR measured during coronarography if there is an intermediate stenosis Regional CFR if there is an intermediate coronary stenosis with medical treatment, after one year of treatment, calculated during a new SPECT CZT exam

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients referred for myocardial ischemia screening

Exclusion Criteria:

Patient already suffering from coronary disease with angioplasty, bypass surgery or myocardial infarction.
Contraindications related to the stress test:

Acute Coronary Syndrome <5 days Unstable angina Stenosis of left main artery untreated Uncontrolled severe rhythm disorders Uncontrolled heart failure

Contraindications to dipyridamole and regadenoson:

Hypotension (systolic <90mmHg) Severe pulmonary arterial hypertension Bradycardia <40 beats / minute Sinusal Dysfunction and 2nd or 3rd degree Atrioventricular block Decompensated Heart Failure with Ejection Fraction <25% Stenosis of supra-aortic trunks unilateral> 70% or bilateral> 50% Dipyridamole and regadenoson allergy