Screening Of CoRonary ArTEry diSease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Grenoble
About this trial
This study is a randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs functional tests, allowing the evaluation of the quality of life of these patients in relation to the health resources used.
In symptomatic patients with an intermediate probability of having stable CAD, i.e., whose pretest or clinical probability does not allow the elimination of the disease, and in patients without anginal symptoms for low levels of exercise who do not respond to medical therapy, in France, the diagnostic care pathways have become mature enough to set up a pragmatic prospective randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs.
Probabilistic medico-economic reasoning makes it possible to establish this two-way hypothesis more easily than in clinical research without the need to impose the superiority of one of the strategies.
Eligibility criteria
Qualifiers
Patients aged 18 to 75 years
Symptomatic patient in whom CAD cannot be excluded by clinical evaluation alone : patient with a pre-test or "intermediate" clinical probability indicating imaging test according to European recommendations
Patient affiliated to the social security system or beneficiary of such a system
Written informed consent
Disqualifiers
Pre-test probability "low" < 5% or 5-15% without additive pejorative factors
Clinical probability of "high" CAD, defined by symptoms typical of low exercise levels not responding to medical therapies
Known history of CAD
Severe impairment of left ventricular ejection fraction < 40%.
Trial design
Treatments tested in this trial
- Coronary CT in 1st line compared to the strategy with functional test in 1st line in patient at Intermediate Risk of Developing Stable Coronary Disease:
Treatment groups
800 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov