Screening Of CoRonary ArTEry diSease (SOCRATES)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Cardiology
• Intervention / Treatment: 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:

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 Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Chambon; Phone Number: 04 76 76 89 35; Email: lchambon@chu-grenoble.fr
• Study Contact Backup: Name: Clémence Charlon; Phone Number: 04 76 76 66 52; Email: ccharlon@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: First line coronary scanner group; 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.	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: 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 functional test strategy group; 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.	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: 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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	1 year
Compare treatment satisfaction at 1 year	SAQ: patients' satisfaction with their current treatment is assessed in questions 5 to 8	1 year
Compare quality of life at 1 year	SAQ: quality of life is assessed in questions 9 to 11 of the questionnaire	1 year
Compare dyspnea at 1 year	ROSE dyspnea scale : grade 1 to 4 (worst condition)	1 year
Compare severity of angina at 1, 2 and 3 years	CCS score (Canadian Cardiovascular Society) : grade asymptomatic to 4 (worst condition)	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.	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	1 year
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.	Time to obtain CAD imaging tests	1 year
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.	Type of CAD imaging tests	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	1 year
Observe deviations in management from current recommendations at 1 year.	Number and percentage of deviations from current recommendations	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	1 year
Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year.	Number and rate of revascularization	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.	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	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	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	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	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Gilles Barone-Rochette, Pr, Chu Grenoble Alpes

Publications and helpful links

General Publications

• Knuuti 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. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4242.
• 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. Erratum In: Circulation. 2016 Apr 12;133(15):e599.
• Roth 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.
• Timmis 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. Erratum In: Eur Heart J. 2020 Dec 14;41(47):4507.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): October 1, 2026
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Medico-economic study; Coronary CT scanner; Cardiac functionel test
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2022-A00302-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No