CCTA, CACS and ECG Stress Testing in Patients With Suspected CAD: Precision Phenotyping and Financial Evaluation

NCT04424121 | Unknown

• 1 other identifier: DATASET PRECISE_01062020_03448
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

Brief Summary

The "DATASET-PRECISE", a 3-arm parallel randomized study, aims to provide new insights in risk stratification of patients with suspected CAD in the Greek population. The convergence of information derived from exercise ECG stress test, CACS, CCTA and metabolomic profiling in artificial intelligence algorithms describes in brief the main objective of this protocol. The design of the present proposal is based on current state-of-the-art literature, incorporating, however, additional innovative elements. It is about the first randomized study to be conducted in Greece, investigating the role of CCTA and CACS in CAD diagnosis and risk assessment. Moreover, the present protocol aims to integrate information on patients' metabolomic profiling. The process of the whole information by using artificial intelligence technology will lead to the development of new risk stratification algorithms, promoting further personalized diagnostic and therapeutic approach. Regarding Greece, this is the first prospectively enrolling medical database of this scale.

Conditions

Stable Angina; Coronary Artery Disease; Atherosclerosis; Coronary Artery Calcification

Keywords

Coronary Computed Tomography Angiography; Coronary Artery Calcium Score; ECG Stress Test; Metabolomics; Precision Medicine; Artificial Intelligence; Machine Learning; Cost-Effectiveness Analysis; Clinical Decision Support Tool

Outcome Measures

Primary Outcomes (2)

• Major Adverse Cardiac Events (MACE)

  Defined as cardiac death, non-fatal myocardial infarction or revascularization with percutaneous coronary intervention or coronary artery bypass graft surgery. Revascularization procedures within 6 weeks after the index CCTA will be excluded because they may be triggered by the CCTA findings per se

  18 months

• Chest-pain rehospitalization

  Frequency (%) of chest-pain rehospitalization

  18 months

Secondary Outcomes (4)

• Frequency of angina [Seattle Angina Questionnaire (SAQ)]

  6 months

• Frequency of angina [Seattle Angina Questionnaire (SAQ)]

  12 months

• Frequency of angina [Seattle Angina Questionnaire (SAQ)]

  18 months

• Generic health status [Medical Outcomes Study 12-Item Short Form (SF-12)]

  12 months

Study Arms (3)

Standard of care plus ECG Stress Testing

NO INTERVENTION

Participants will be approached and randomized to receive standard care plus ECG-stress testing

Standard of care plus ECG Stress Testing and CACS

NO INTERVENTION

Participants will be approached and randomized to receive standard care plus ECG-stress testing and coronary artery calcium scoring

Standard of care plus CCTA

ACTIVE COMPARATOR

Participants will be approached and randomized to receive standard care plus ≥ 64 multidetector coronary computed tomography angiography

Diagnostic Test: CCTA

Interventions

CCTA DIAGNOSTIC_TEST

Coronary Computed Tomography Angiography

Standard of care plus CCTA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable symptoms and low to intermediate probability of coronary artery disease (CAD) referred for evaluation
• Patients without known history of CAD
• Patients older than 18 years
• Patients giving voluntary written consent to participate in the study
• Subject is willing to comply with study follow-up requirements

You may not qualify if:

• Patients with a previous history of CAD
• Patients who refuse to give written consent for participation in the study
• In the investigator's opinion, subject will not be able to comply with the follow-up requirements
• Known pregnancy
• Subject has a known allergy to contrast agent that cannot be adequately pre-medicated
• Inability or unwilling to undergo computed tomography scanning, such as exceeding weight tolerance of scanner
• Severe renal failure (estimated Glomerular Filtration Rate-eGFR \<30 mL/min)

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Lefkos Stavros The Athens Clinic: collaborator
• National and Kapodistrian University of Athens: collaborator

Study Sites (3)

Lefkos Stavros The Athens Clinic

Athens, Greece

Location

National and Kapodistrian University of Athens, School of Medicine

Athens, Greece

Location

Aristotle University of Thessaloniki, School of Medicine

Thessaloniki, Greece

Location

Related Publications (8)

• Benz DC, Benetos G, Rampidis G, von Felten E, Bakula A, Sustar A, Kudura K, Messerli M, Fuchs TA, Gebhard C, Pazhenkottil AP, Kaufmann PA, Buechel RR. Validation of deep-learning image reconstruction for coronary computed tomography angiography: Impact on noise, image quality and diagnostic accuracy. J Cardiovasc Comput Tomogr. 2020 Sep-Oct;14(5):444-451. doi: 10.1016/j.jcct.2020.01.002. Epub 2020 Jan 13.

  PMID: 31974008 BACKGROUND

• Benetos G, Buechel RR, Goncalves M, Benz DC, von Felten E, Rampidis GP, Clerc OF, Messerli M, Giannopoulos AA, Gebhard C, Fuchs TA, Pazhenkottil AP, Kaufmann PA, Grani C. Coronary artery volume index: a novel CCTA-derived predictor for cardiovascular events. Int J Cardiovasc Imaging. 2020 Apr;36(4):713-722. doi: 10.1007/s10554-019-01750-2. Epub 2020 Jan 1.

  PMID: 31894527 BACKGROUND

• Rampidis GP, Benetos G, Benz DC, Giannopoulos AA, Buechel RR. A guide for Gensini Score calculation. Atherosclerosis. 2019 Aug;287:181-183. doi: 10.1016/j.atherosclerosis.2019.05.012. Epub 2019 May 10. No abstract available.

  PMID: 31104809 BACKGROUND

• 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.

  PMID: 31504439 BACKGROUND

• Budoff MJ, Mayrhofer T, Ferencik M, Bittner D, Lee KL, Lu MT, Coles A, Jang J, Krishnam M, Douglas PS, Hoffmann U; PROMISE Investigators. Prognostic Value of Coronary Artery Calcium in the PROMISE Study (Prospective Multicenter Imaging Study for Evaluation of Chest Pain). Circulation. 2017 Nov 21;136(21):1993-2005. doi: 10.1161/CIRCULATIONAHA.117.030578. Epub 2017 Aug 28.

  PMID: 28847895 BACKGROUND

• SCOT-HEART Investigators; Newby DE, Adamson PD, Berry C, Boon NA, Dweck MR, Flather M, Forbes J, Hunter A, Lewis S, MacLean S, Mills NL, Norrie J, Roditi G, Shah ASV, Timmis AD, van Beek EJR, Williams MC. Coronary CT Angiography and 5-Year Risk of Myocardial Infarction. N Engl J Med. 2018 Sep 6;379(10):924-933. doi: 10.1056/NEJMoa1805971. Epub 2018 Aug 25.

  PMID: 30145934 BACKGROUND

• Hilvo M, Meikle PJ, Pedersen ER, Tell GS, Dhar I, Brenner H, Schottker B, Laaperi M, Kauhanen D, Koistinen KM, Jylha A, Huynh K, Mellett NA, Tonkin AM, Sullivan DR, Simes J, Nestel P, Koenig W, Rothenbacher D, Nygard O, Laaksonen R. Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients. Eur Heart J. 2020 Jan 14;41(3):371-380. doi: 10.1093/eurheartj/ehz387.

  PMID: 31209498 BACKGROUND

• von Felten E, Messerli M, Giannopoulos AA, Benz DC, Schwyzer M, Benetos G, Rampidis G, Patriki D, Kamani CH, Grani C, Fuchs TA, Pazhenkottil AP, Gebhard C, Kaufmann PA, Buechel RR. Potential of Radiation Dose Reduction by Optimizing Z-Axis Coverage in Coronary Computed Tomography Angiography on a Latest-Generation 256-Slice Scanner. J Comput Assist Tomogr. 2020 Mar/Apr;44(2):289-294. doi: 10.1097/RCT.0000000000000993.

  PMID: 32195809 BACKGROUND

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Haralambos Karvounis, Prof. in Cardiology

  Aristotle University Of Thessaloniki

  STUDY CHAIR

• Georgios Giannakoulas, Prof. in Cardiology

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

• Periklis Kounatiadis, MD, PhD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Panagiotis Bamidis, Prof. in Bioinformatics

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Georgios Rampidis, MD, MSc

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Olga Deda, PhD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Antonios Billis, PhD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios Rampidis, MD, MSc

CONTACT

2310994830; grampidi@auth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label, 3-arm parallel randomized study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Scholar

Model Details: Open-label, 3-arm parallel randomized study

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 9, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3)