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Completed

NCT Number: NCT03586492

Coronary Flow Reserve (CFR) in Cardiovascular Risk Stratification

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.

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Key information

Conditions

Ischemia, Myocardial Cardiovascular Diseases Heart Diseases Ischemic Heart Disease Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR d'Orleans, Orléans, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients with pacemaker, or who have had valvular surgery,
  • Well-known dilated cardiopathy
  • Pregnant or breastfeeding women,
  • Minor people
  • Persons under guardianship or under guardianship

Treatment and study plan

CZT SPECT acquisition

Diagnostic Test

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

Primary outcomes

  1. Regional and global CFR

    Time frame: Day 0

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

Secondary outcomes

  1. FFR Regional CFR after one year of medical treatment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: CFR-OR

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2018
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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