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

NCT04424121 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2020-09-14

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

CCTA

Coronary Computed Tomography Angiography

Sponsors & Collaborators

  • Lefkos Stavros The Athens Clinic

    collaborator UNKNOWN
  • National and Kapodistrian University of Athens

    collaborator OTHER
  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Haralambos Karvounis, Prof. in Cardiology · Aristotle University Of Thessaloniki

  • Georgios Giannakoulas, Prof. in Cardiology · Aristotle University Of Thessaloniki

  • Periklis Kounatiadis, MD, PhD · Aristotle University Of Thessaloniki

  • Panagiotis Bamidis, Prof. in Bioinformatics · Aristotle University Of Thessaloniki

  • Georgios Rampidis, MD, MSc · Aristotle University Of Thessaloniki

  • Olga Deda, PhD · Aristotle University Of Thessaloniki

  • Antonios Billis, PhD · Aristotle University Of Thessaloniki

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Greece

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04424121 on ClinicalTrials.gov