CardiologySOCRATESNCT05369728
Screening Of CoRonary ArTEry diSease
A study testing 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: in people with Cardiology and Coronary Artery Disease, run by University Hospital, Grenoble.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiology, Coronary Artery Disease
- What is being tested?
- 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:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%.
- Known chronic renal failure not on dialysis (GFR <30 ml / min /1.73 m²)
- Patient considered unfit for the study according to the investigator's judgement and in particular the impossibility of performing an anatomical and/or functional test of ischemia of the coronary disease
Show all 9Show fewer
- Patient in a period of exclusion for another study
- Persons referred to in articles L1121-5 to L1121-8 of the public health code
- Patient participating in another interventional research
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the detailed description
In Europe, cardiovascular disease remains the leading cause of death with 4 million deaths per year, of which 1.8 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: 3.3% 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, 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.
- Conditions
- Cardiology, Coronary Artery Disease
- Being tested
- 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:
- Keywords
- Medico-economic study, Coronary CT scanner, Cardiac functionel test
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Coronary CT in 1st line compared to the strategy with functional test in 1st line in Patients at Intermediate Risk of Developing Stable Coronary Disease:
| Study group | Role | What they receive |
|---|---|---|
| First line coronary scanner group | Other | The patient will benefit from a coronary CT scan in 1st line (evaluation of the coronary anatomy), then according to the result it will be managed according to the CAD-RADS decision algorithm. Receives: Other: 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: |
| First line functional test strategy group | Other | The patient benefits from a functional test in 1st line (search for myocardial ischemia by myocardial scintigraphy: SPECT, stress echography, or MRI), then according to the result he will be managed in accordance with the European recommendations. Receives: Other: 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: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (20)
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.
Measured: 10 years
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
Measured: 3 and 5 years
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
Measured: 1 year
Compare treatment satisfaction at 1 year
SAQ: patients' satisfaction with their current treatment is assessed in questions 5 to 8
Measured: 1 year
Compare quality of life at 1 year
SAQ: quality of life is assessed in questions 9 to 11 of the questionnaire
Measured: 1 year
Compare dyspnea at 1 year
ROSE dyspnea scale : grade 1 to 4 (worst condition)
Measured: 1 year
Compare severity of angina at 1, 2 and 3 years
CCS score (Canadian Cardiovascular Society) : grade asymptomatic to 4 (worst condition)
Measured: 1, 2 and 3 years
Compare quality of life at 1, 2 and 3 years
Quality of life: EuroQol 5D-5 : cotation from 0 (worst condition) to 1.
Measured: 1, 2 and 3 years
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
Number of CAD imaging tests
Measured: 1 year
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
Time to obtain CAD imaging tests
Measured: 1 year
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
Type of CAD imaging tests
Measured: 1 year
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
Treatments used after the first line examination to manage chest pain symptomatology
Measured: 1 year
Observe deviations in management from current recommendations at 1 year.
Number and percentage of deviations from current recommendations
Measured: 1 year
Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year.
Number and rate of coronary angiography with or without FFR/iwFR
Measured: 1 year
Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year.
Number and rate of revascularization
Measured: 1 year
Compare major clinical events at 1, 2 and 3 years.
Deaths from cardiovascular causes, myocardial infarction, or ischemia-guided revascularization, heart failure, or recovered cardiac arrest.
Measured: 1, 2 and 3 years.
Compare the radiation exposure of patients for each strategy at 1 year.
Measurement of radiation exposure related to cardiovascular tests and procedures in millisieverts
Measured: 1 year
To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina.
New indexes from post image processing
Measured: 1 year
To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina.
QUALY
Measured: 1 year
To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina.
SAQ (Seattle Angina questionnaire) question 1 to 19
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study startMay 2022 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CardiologyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Barone-Rochette, Pr, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369728
- Sponsor's protocol ID
- 2022-A00302-41
- Acronym
- SOCRATES
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2022
- Last updated
- 11 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
PubMed 26673558Roth GA, Johnson C, Abajobir A, Abd-Allah F, Abera SF, Abyu G, Ahmed M, Aksut B, Alam T, Alam K, Alla F, Alvis-Guzman N, Amrock S, Ansari H, Arnlov J, Asayesh H, Atey TM, Avila-Burgos L, Awasthi A, Banerjee A, Barac A, Barnighausen T, Barregard L, Bedi N, Belay Ketema E, Bennett D, Berhe G, Bhutta Z, Bitew S, Carapetis J, Carrero JJ, Malta DC, Castaneda-Orjuela CA, Castillo-Rivas J, Catala-Lopez F, Choi JY, Christensen H, Cirillo M, Cooper L Jr, Criqui M, Cundiff D, Damasceno A, Dandona L, Dandona R, Davletov K, Dharmaratne S, Dorairaj P, Dubey M, Ehrenkranz R, El Sayed Zaki M, Faraon EJA, Esteghamati A, Farid T, Farvid M, Feigin V, Ding EL, Fowkes G, Gebrehiwot T, Gillum R, Gold A, Gona P, Gupta R, Habtewold TD, Hafezi-Nejad N, Hailu T, Hailu GB, Hankey G, Hassen HY, Abate KH, Havmoeller R, Hay SI, Horino M, Hotez PJ, Jacobsen K, James S, Javanbakht M, Jeemon P, John D, Jonas J, Kalkonde Y, Karimkhani C, Kasaeian A, Khader Y, Khan A, Khang YH, Khera S, Khoja AT, Khubchandani J, Kim D, Kolte D, Kosen S, Krohn KJ, Kumar GA, Kwan GF, Lal DK, Larsson A, Linn S, Lopez A, Lotufo PA, El Razek HMA, Malekzadeh R, Mazidi M, Meier T, Meles KG, Mensah G, Meretoja A, Mezgebe H, Miller T, Mirrakhimov E, Mohammed S, Moran AE, Musa KI, Narula J, Neal B, Ngalesoni F, Nguyen G, Obermeyer CM, Owolabi M, Patton G, Pedro J, Qato D, Qorbani M, Rahimi K, Rai RK, Rawaf S, Ribeiro A, Safiri S, Salomon JA, Santos I, Santric Milicevic M, Sartorius B, Schutte A, Sepanlou S, Shaikh MA, Shin MJ, Shishehbor M, Shore H, Silva DAS, Sobngwi E, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadele Atnafu N, Tesfay F, Thakur JS, Thrift A, Topor-Madry R, Truelsen T, Tyrovolas S, Ukwaja KN, Uthman O, Vasankari T, Vlassov V, Vollset SE, Wakayo T, Watkins D, Weintraub R, Werdecker A, Westerman R, Wiysonge CS, Wolfe C, Workicho A, Xu G, Yano Y, Yip P, Yonemoto N, Younis M, Yu C, Vos T, Naghavi M, Murray C. Global, Regional, and National Burden of Cardiovascular Diseases for 10 Causes, 1990 to 2015. J Am Coll Cardiol. 2017 Jul 4;70(1):1-25. doi: 10.1016/j.jacc.2017.04.052. Epub 2017 May 17.
PubMed 28527533Timmis A, Townsend N, Gale CP, Torbica A, Lettino M, Petersen SE, Mossialos EA, Maggioni AP, Kazakiewicz D, May HT, De Smedt D, Flather M, Zuhlke L, Beltrame JF, Huculeci R, Tavazzi L, Hindricks G, Bax J, Casadei B, Achenbach S, Wright L, Vardas P; European Society of Cardiology. European Society of Cardiology: Cardiovascular Disease Statistics 2019. Eur Heart J. 2020 Jan 1;41(1):12-85. doi: 10.1093/eurheartj/ehz859.
PubMed 31820000Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
PubMed 31504439
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05369728
- Acronym / sponsor ID
- SOCRATES / 2022-A00302-41
- Conditions
- Cardiology, Coronary Artery Disease
- Keywords
- Medico-economic study, Coronary CT scanner, Cardiac functionel test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In Europe, cardiovascular disease remains the leading cause of death with 4 million deaths per year, of which 1.8 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: 3.3% 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, 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First line coronary scanner group | Other | Other: 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:The patient will benefit from a coronary CT scan in 1st line (evaluation of the coronary anatomy), then according to the result it will be managed according to the CAD-RADS decision algorithm. |
| First line functional test strategy group | Other | Other: 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:The patient benefits from a functional test in 1st line (search for myocardial ischemia by myocardial scintigraphy: SPECT, stress echography, or MRI), then according to the result he will be managed in accordance with the European recommendations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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%.
- Known chronic renal failure not on dialysis (GFR <30 ml / min /1.73 m²)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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:Coronary CT in 1st line compared to the strategy with functional test in 1st line in Patients at Intermediate Risk of Developing Stable Coronary Disease: | Other | First line coronary scanner group, First line functional test strategy group |
Primary outcome
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.
Time frame: 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.
20 secondary outcomes
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.
Time frame: 10 years
Conduct a budget impact analysis (BIA) from the National Health System's perspective at 3 and 5 years.
Time frame: 3 and 5 years
To compare angina symptoms (limitation, stability, frequency) at 1 year.
Time frame: 1 year
Compare treatment satisfaction at 1 year
Time frame: 1 year
Compare quality of life at 1 year
Time frame: 1 year
Compare dyspnea at 1 year
Time frame: 1 year
Compare severity of angina at 1, 2 and 3 years
Time frame: 1, 2 and 3 years
Compare quality of life at 1, 2 and 3 years
Time frame: 1, 2 and 3 years
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
Time frame: 1 year
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
Time frame: 1 year
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
Time frame: 1 year
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
Time frame: 1 year
Observe deviations in management from current recommendations at 1 year.
Time frame: 1 year
Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year.
Time frame: 1 year
Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year.
Time frame: 1 year
Compare major clinical events at 1, 2 and 3 years.
Time frame: 1, 2 and 3 years.
Compare the radiation exposure of patients for each strategy at 1 year.
Time frame: 1 year
To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina.
Time frame: 1 year
To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina.
Time frame: 1 year
To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 26673558Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
- Background: PubMed 28527533Roth GA, Johnson C, Abajobir A, Abd-Allah F, Abera SF, Abyu G, Ahmed M, Aksut B, Alam T, Alam K, Alla F, Alvis-Guzman N, Amrock S, Ansari H, Arnlov J, Asayesh H, Atey TM, Avila-Burgos L, Awasthi A, Banerjee A, Barac A, Barnighausen T, Barregard L, Bedi N, Belay Ketema E, Bennett D, Berhe G, Bhutta Z, Bitew S, Carapetis J, Carrero JJ, Malta DC, Castaneda-Orjuela CA, Castillo-Rivas J, Catala-Lopez F, Choi JY, Christensen H, Cirillo M, Cooper L Jr, Criqui M, Cundiff D, Damasceno A, Dandona L, Dandona R, Davletov K, Dharmaratne S, Dorairaj P, Dubey M, Ehrenkranz R, El Sayed Zaki M, Faraon EJA, Esteghamati A, Farid T, Farvid M, Feigin V, Ding EL, Fowkes G, Gebrehiwot T, Gillum R, Gold A, Gona P, Gupta R, Habtewold TD, Hafezi-Nejad N, Hailu T, Hailu GB, Hankey G, Hassen HY, Abate KH, Havmoeller R, Hay SI, Horino M, Hotez PJ, Jacobsen K, James S, Javanbakht M, Jeemon P, John D, Jonas J, Kalkonde Y, Karimkhani C, Kasaeian A, Khader Y, Khan A, Khang YH, Khera S, Khoja AT, Khubchandani J, Kim D, Kolte D, Kosen S, Krohn KJ, Kumar GA, Kwan GF, Lal DK, Larsson A, Linn S, Lopez A, Lotufo PA, El Razek HMA, Malekzadeh R, Mazidi M, Meier T, Meles KG, Mensah G, Meretoja A, Mezgebe H, Miller T, Mirrakhimov E, Mohammed S, Moran AE, Musa KI, Narula J, Neal B, Ngalesoni F, Nguyen G, Obermeyer CM, Owolabi M, Patton G, Pedro J, Qato D, Qorbani M, Rahimi K, Rai RK, Rawaf S, Ribeiro A, Safiri S, Salomon JA, Santos I, Santric Milicevic M, Sartorius B, Schutte A, Sepanlou S, Shaikh MA, Shin MJ, Shishehbor M, Shore H, Silva DAS, Sobngwi E, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadele Atnafu N, Tesfay F, Thakur JS, Thrift A, Topor-Madry R, Truelsen T, Tyrovolas S, Ukwaja KN, Uthman O, Vasankari T, Vlassov V, Vollset SE, Wakayo T, Watkins D, Weintraub R, Werdecker A, Westerman R, Wiysonge CS, Wolfe C, Workicho A, Xu G, Yano Y, Yip P, Yonemoto N, Younis M, Yu C, Vos T, Naghavi M, Murray C. Global, Regional, and National Burden of Cardiovascular Diseases for 10 Causes, 1990 to 2015. J Am Coll Cardiol. 2017 Jul 4;70(1):1-25. doi: 10.1016/j.jacc.2017.04.052. Epub 2017 May 17.
- Background: PubMed 31820000Timmis A, Townsend N, Gale CP, Torbica A, Lettino M, Petersen SE, Mossialos EA, Maggioni AP, Kazakiewicz D, May HT, De Smedt D, Flather M, Zuhlke L, Beltrame JF, Huculeci R, Tavazzi L, Hindricks G, Bax J, Casadei B, Achenbach S, Wright L, Vardas P; European Society of Cardiology. European Society of Cardiology: Cardiovascular Disease Statistics 2019. Eur Heart J. 2020 Jan 1;41(1):12-85. doi: 10.1093/eurheartj/ehz859.
- Background: PubMed 31504439Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Barone-Rochette, Pr principal investigator
CHU Grenoble Alpes
Questions about this trial
What is this clinical trial studying?
A study testing 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: in people with Cardiology and Coronary Artery Disease, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Chambon (04 76 76 89 35, lchambon@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369728, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.