NCT03586492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

July 3, 2018

Last Update Submit

December 4, 2020

Conditions

Ischemia, MyocardialIschemic Heart Disease

Keywords

CFRSPECTCZTCoronaryCalcium scoreScintigraphyMyocardial perfusion

Outcome Measures

Primary Outcomes (1)

  • Regional and global CFR

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

    Day 0

Secondary Outcomes (1)

  • FFR Regional CFR after one year of medical treatment

    Up to one year

Study Arms (1)

Patient with myocardial ischemia

OTHER
Diagnostic Test: CZT SPECT acquisition

Interventions

CZT SPECT acquisitionDIAGNOSTIC_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

Patient with myocardial ischemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for myocardial ischemia screening

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHR d'Orleans

Orléans, 45067, France

Location

CHRU de Tours

Tours, 37000, France

Location

Related Publications (4)

  • 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.

    PMID: 2407762BACKGROUND

  • 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.

    PMID: 29497801BACKGROUND

  • 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.

    PMID: 26780529BACKGROUND

  • 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.

    PMID: 26338893BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Matthieu BAILLY, Dr

    CHR d'Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 13, 2018

Study Start

November 5, 2018

Primary Completion

November 5, 2020

Study Completion

November 5, 2020

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)