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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
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:
Other interventionCoronary CT in 1st line compared to the strategy with functional test in 1st line in Patients at Intermediate Risk of Developing Stable Coronary Disease:
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: First line coronary scanner groupOther 1 intervention
Group B: First line functional test strategy groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Conduct a cost-utility analysis (CUA) comparing the strategy "CCTA in 1st line" to the strategy "functional test in 1st line" in patients with suspected stable CAD in a collective perspective, at 1 year.
The incremental cost-utility ratio (ICER) will be calculated by relating the difference in costs to the difference in the average number of QALYs. The ratio will therefore be expressed as cost per QALY gained, which represents the additional cost of gaining one year of healthy life with the "CCTA" strategy vs. the "functional test" strategy. Since CCTA is a special case of CEA, the incremental cost-effectiveness ratio (ICER) expressed as the incremental cost per life-year gained will also be calculated.
Time frame
1 yearSecondary outcomes
1
To model in the long term (10 years) the impact of the 2 diagnostic strategies in terms of cost and consequences as defined in the main objective.
Incremental cost-effectiveness ratio (ICER and ICER) at 10 years as defined in Primary Objective 1.
Time frame
10 years2
Conduct a budget impact analysis (BIA) from the National Health System's perspective at 3 and 5 years.
Measure the financial impact on the National Health System of the deployment of the CCTA strategy in 3 and 5 years
Time frame
3 and 5 years3
To compare angina symptoms (limitation, stability, frequency) at 1 year.
SAQ (Seattle Angina Questionnaire): physical limitation is assessed by question 1; angina stability by question 2 and angina frequency by questions 3 and 4
Time frame
1 year4
Compare treatment satisfaction at 1 year
SAQ: patients' satisfaction with their current treatment is assessed in questions 5 to 8
Time frame
1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: