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

Primary Purpose

Ischemia, Myocardial, Ischemic Heart Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CZT SPECT acquisition
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemia, Myocardial focused on measuring CFR, SPECT, CZT, Coronary, Calcium score, Scintigraphy, Myocardial perfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

  • 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

Sites / Locations

  • CHR d'Orleans
  • CHRU de Tours

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient with myocardial ischemia

Arm Description

Outcomes

Primary Outcome Measures

Regional and global CFR
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
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

Full Information

First Posted
July 3, 2018
Last Updated
December 4, 2020
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT03586492
Brief Title
Coronary Flow Reserve (CFR) in Cardiovascular Risk Stratification
Acronym
CFR-OR
Official Title
SPECT Myocardial Perfusion Reserve Using a Cadmium Zinc Telluride (CZT) Camera in Cardiovascular Risk Stratification and Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Myocardial, Ischemic Heart Disease
Keywords
CFR, SPECT, CZT, Coronary, Calcium score, Scintigraphy, Myocardial perfusion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with myocardial ischemia
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
CZT SPECT acquisition
Intervention Description
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 Outcome Measure Information:
Title
Regional and global CFR
Description
Regional and global CFR calculated from CZT SPECT myocardial perfusion: correlation with clinical score and calcium score
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
FFR Regional CFR after one year of medical treatment
Description
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
Time Frame
Up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu BAILLY, Dr
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orleans
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
CHRU de Tours
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2407762
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.
Results Reference
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PubMed Identifier
29497801
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.
Results Reference
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PubMed Identifier
26780529
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.
Results Reference
background
PubMed Identifier
26338893
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.
Results Reference
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Coronary Flow Reserve (CFR) in Cardiovascular Risk Stratification

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