Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05369728
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-05-11
First Post:
2022-04-28
Brief Title:
Screening Of CoRonary ArTEry diSease
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Medico-economic Evaluation of a Strategy With Coronary CT as First Line CCTA Compared With the Strategy With Functional Test as First Line in Patients at Intermediate Risk of Developing Stable Coronary Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOCRATES
Brief Summary:
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 ie 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
In symptomatic patients with an intermediate probability of having stable CAD ie 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
Detailed Description:
In Europe cardiovascular disease remains the leading cause of death with 4 million deaths per year of which 18 million are due to coronary heart disease CHD CAD also has a cost with 46 billion year spent for its management In France 4 billion are spent on it which shows that it remains a public health problem and that most of the premature events are avoidable in particular by screening patients with symptoms that make them suspect it In these symptomatic patients suspected of having CAD screening is carried out in particular through the use of imaging with technological innovations and performances that are constantly being improved and validated in large randomized trials
The PROMISE trial randomized an impressive number of 10003 patients comparing coronary computed tomography angiography CCTA and functional testing to assess suspected CAD which showed similar efficacy of the 2 strategies in terms of major adverse cardiovascular events MACE at 2 years 33 for CCTA and 3 for functional testing Thus the 2019 European guidelines allow CCTA or functional testing as the initial test to diagnose CAD in symptomatic patients Thus clinicians now have 2 first-line strategies CCTA or functional tests myocardial scintigraphy echocardiography MRI The clinician can choose to initiate management with an anatomic evaluation of the coronary arteries CCTA or a search for ischemia functional test These two ways of assessing CAD are very different and are the subject of debate in Europe For example the National Institute of Health and Care Excellence NICE in the United Kingdom now recommends CCTA as the first test unlike in Europe
In view of all these arguments it is relevant to propose a randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies CCTA vs functional tests making it possible to evaluate 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 ie 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
The PROMISE trial randomized an impressive number of 10003 patients comparing coronary computed tomography angiography CCTA and functional testing to assess suspected CAD which showed similar efficacy of the 2 strategies in terms of major adverse cardiovascular events MACE at 2 years 33 for CCTA and 3 for functional testing Thus the 2019 European guidelines allow CCTA or functional testing as the initial test to diagnose CAD in symptomatic patients Thus clinicians now have 2 first-line strategies CCTA or functional tests myocardial scintigraphy echocardiography MRI The clinician can choose to initiate management with an anatomic evaluation of the coronary arteries CCTA or a search for ischemia functional test These two ways of assessing CAD are very different and are the subject of debate in Europe For example the National Institute of Health and Care Excellence NICE in the United Kingdom now recommends CCTA as the first test unlike in Europe
In view of all these arguments it is relevant to propose a randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies CCTA vs functional tests making it possible to evaluate 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None