Clinical trial NCT03586492: Coronary Flow Reserve (CFR) in Cardiovascular Risk Stratification
Official title: SPECT Myocardial Perfusion Reserve Using a Cadmium Zinc Telluride (CZT) Camera in Cardiovascular Risk Stratification and Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemia, Myocardial
Ischemic Heart Disease
Keywords: CFR
SPECT
CZT
Coronary
Calcium score
Scintigraphy
Myocardial perfusion
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Regional and global CFR
timeFrame: Day 0
Secondary outcomes:
measure: FFR Regional CFR after one year of medical treatment
timeFrame: Up to one year
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orleans
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: CHR d'Orléans
name: Matthieu BAILLY, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.