NCT02278497

Brief Summary

The study will assess coronary flow reserve by PET-H215O and FFR in patients suspected of coroanry artery disease. This a comparative study with dynamic acquisition using CZT camera and 99mcTc-mibi. 20 patients will have those measurements.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

October 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

October 28, 2014

Last Update Submit

July 30, 2015

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Assess myocardial coronary reserve by cardiac CZT camera and Tcmibi comparing with the PET and the water marked during coronary FFR (Flow Fraction Reserve)

    baseline

Study Arms (1)

ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR

OTHER
Other: ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR

Interventions

ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFROTHER
ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient between 18 and 80 years
  • Suspected coronary disease and / or coronary syndrome patient ST-
  • Patient who has been informed of the study and has given his informed consent
  • Patient affiliated to a social security system.

You may not qualify if:

  • Patient having no coronary disease at coronary angiography with FFR on the 3 main epicardial arteries (absence of ≥ 50% stenosis of at least one artery)
  • Delay of Care grater than 30 days between the PET and SPECT imaging and the diagnostic coronary angiography
  • Patient with a recent history of myocardial infarction and STEMI, unstable angina
  • Patient with extra-cardiac disease whose prognosis can interfere with the treatment decision
  • Pregnant or lactating women
  • Patient allergic to contrast products during coronary angiography
  • Patient with MDRD clearance les than 60 ml / min
  • Patient Under guardianship, or unable to understand the purpose of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medecine Nucleaire

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

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

October 28, 2014

First Posted

October 30, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

FR(1)