Clinical trial NCT05369728: Screening Of CoRonary ArTEry diSease
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiology
Coronary Artery Disease
Keywords: Medico-economic study
Coronary CT scanner
Cardiac functionel test
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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, 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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 10 years
measure: Conduct a budget impact analysis (BIA) from the National Health System's perspective at 3 and 5 years.
timeFrame: 3 and 5 years
measure: To compare angina symptoms (limitation, stability, frequency) at 1 year.
timeFrame: 1 year
measure: Compare treatment satisfaction at 1 year
timeFrame: 1 year
measure: Compare quality of life at 1 year
timeFrame: 1 year
measure: Compare dyspnea at 1 year
timeFrame: 1 year
measure: Compare severity of angina at 1, 2 and 3 years
timeFrame: 1, 2 and 3 years
measure: Compare quality of life at 1, 2 and 3 years
timeFrame: 1, 2 and 3 years
measure: Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
timeFrame: 1 year
measure: Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
timeFrame: 1 year
measure: Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
timeFrame: 1 year
measure: Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
timeFrame: 1 year
measure: Observe deviations in management from current recommendations at 1 year.
timeFrame: 1 year
measure: Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year.
timeFrame: 1 year
measure: Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year.
timeFrame: 1 year
measure: Compare major clinical events at 1, 2 and 3 years.
timeFrame: 1, 2 and 3 years.
measure: Compare the radiation exposure of patients for each strategy at 1 year.
timeFrame: 1 year
measure: To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina.
timeFrame: 1 year
measure: To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina.
timeFrame: 1 year
measure: To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: CHU Grenoble Alpes
name: Gilles Barone-Rochette, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.