Coronary Flow Reserve (CFR) in Cardiovascular Risk Stratification

NCT ID: NCT03586492

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2020-11-05

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Ischemia, Myocardial Ischemic Heart Disease

Keywords

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CFR SPECT CZT Coronary Calcium score Scintigraphy Myocardial perfusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient with myocardial ischemia

Group Type OTHER

CZT SPECT acquisition

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu BAILLY, Dr

Role: PRINCIPAL_INVESTIGATOR

CHR d'Orléans

Locations

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CHR d'Orleans

Orléans, , France

Site Status

CHRU de Tours

Tours, , France

Site Status

Countries

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France

References

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Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol. 1990 Mar 15;15(4):827-32. doi: 10.1016/0735-1097(90)90282-t.

Reference Type BACKGROUND
PMID: 2407762 (View on PubMed)

Agostini D, Roule V, Nganoa C, Roth N, Baavour R, Parienti JJ, Beygui F, Manrique A. First validation of myocardial flow reserve assessed by dynamic 99mTc-sestamibi CZT-SPECT camera: head to head comparison with 15O-water PET and fractional flow reserve in patients with suspected coronary artery disease. The WATERDAY study. Eur J Nucl Med Mol Imaging. 2018 Jul;45(7):1079-1090. doi: 10.1007/s00259-018-3958-7. Epub 2018 Mar 1.

Reference Type BACKGROUND
PMID: 29497801 (View on PubMed)

Assante R, Zampella E, Arumugam P, Acampa W, Imbriaco M, Tout D, Petretta M, Tonge C, Cuocolo A. Quantitative relationship between coronary artery calcium and myocardial blood flow by hybrid rubidium-82 PET/CT imaging in patients with suspected coronary artery disease. J Nucl Cardiol. 2017 Apr;24(2):494-501. doi: 10.1007/s12350-015-0359-1. Epub 2016 Jan 15.

Reference Type BACKGROUND
PMID: 26780529 (View on PubMed)

Ben Bouallegue F, Roubille F, Lattuca B, Cung TT, Macia JC, Gervasoni R, Leclercq F, Mariano-Goulart D. SPECT Myocardial Perfusion Reserve in Patients with Multivessel Coronary Disease: Correlation with Angiographic Findings and Invasive Fractional Flow Reserve Measurements. J Nucl Med. 2015 Nov;56(11):1712-7. doi: 10.2967/jnumed.114.143164. Epub 2015 Sep 3.

Reference Type BACKGROUND
PMID: 26338893 (View on PubMed)

Other Identifiers

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CHRO-2018-05

Identifier Type: -

Identifier Source: org_study_id