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

September 10, 2020 updated by: Georgios P Rampidis, MD, MSc, Aristotle University Of Thessaloniki

Cardiac CT, Calcium Scoring and ECG Stress Testing in Patients With Suspected Coronary Artery Disease: Precision Phenotyping and Financial Evaluation (The DATASET-PRECISE Randomized Trial)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Symptom-based pre-test probability (PTP) scores that estimate the likelihood of obstructive CAD in stable chest pain have moderate accuracy. Appreciating and integrating the myriad risk predictors in an individual patient is a challenge for the clinician. To date, efforts to improve risk-stratification by using CCTA have largely relied upon luminal stenosis severity. The emphasis placed on this variable over others is in alignment with prior studies using invasive coronary angiography but ignores an array of other parameters important in the CAD pathogenic process, including coronary artery geometry, coronary calcium content, plaque composition, and plaque burden. As an increasing number of CCTA variables along with all clinical and metabolomic variables affecting risk need to be considered, the complexity of assessment increases, making it more difficult for a clinician to draw an overall conclusion regarding risk in an individual patient. Furthermore, the potential influence of unexpected interactions between several weaker predictors in an individual patient is often overlooked. In this study, we are seeking to develop an Artificial Intelligence (AI)-based model, utilizing clinical and metabolomic risk factors, serum biomarkers, CCTA imaging biomarkers, coronary artery calcium score and ECG stress testing variables, to predict the presence and the complexity of CAD. Moreover, we are trying to introduce an easy to use, cost-effective, clinical decision supporting tool. In clinical practice, the utilization of such an approach could improve risk stratification and help guide downstream personalized management. Briefly, the research objectives of the study are: 1. predict the risk of obstructive coronary artery disease, 2. quantify the burden and complexity of coronary atherosclerosis, 3. evaluate the prognostic risk in individual patients with suspected CAD, 4. provide more accurate diagnosis and risk stratification, 5. provide an easy to use, cost-effective clinical decision support tool, 6. improve decisions in low to intermediate risk patients regarding the need for further testing such as cardiac SPECT and invasive coronary angiography, as well as for the need for preventive therapies and finally, compare three diagnostic strategies in patients with suspected CAD in terms of efficacy and cost-effectiveness.

The "DATASET-PRECISE" is a prospective, multi-center, open-label, 3-arm parallel randomized study. Following clinical consultation, participants will be approached and randomized 1:1:1 to receive standard care plus ECG-stress testing or standard care plus ECG-stress testing and CACS or standard care plus ≥ 64-multidetector CCTA and CACS (Collaborating Organizations: 1st Cardiology Department of AUTH, 1st Cardiology Department of NKUA, Lefkos Stavros-The Athens Clinic & Affidea Kozani Cardiac Imaging Center). Randomization will be conducted using a web-based system to ensure allocation concealment. The trial will enroll consecutive patients with stable symptoms and suspected CAD admitted to study clinical sites over a period of 12 months. Patients with a previous history of CAD and/or prior revascularization will be excluded. Subjects will undergo screening during the first day of examination, a 5ml blood sample will be collected one minute prior examination for metabolomic analysis (collaboration with the Lab. of Bioanalysis & Toxicology, School of Medicine, AUTH) and will be followed for 18 months afterwards. The overall recruitment period is expected to last 12 months. The estimated total duration of the study from first patient screened to last patient last visit is 30 months.

Based on previous studies for 80% power at a two-sided P value of 0.05, we will need to recruit about 250 patients per group to detect a relative reduction in the combined MACE rate (cardiac death, non-fatal myocardial infarction, revascularization or chest-pain rehospitalization) of 10% in the CCTA arm. A sample size of N = 900 patients is a pragmatic approach for such a first clinical study in the Greek population. Health service costs will be assigned to the type and intensity of resource use, measured by the number of diagnostic and therapeutic procedures or interventions, medications, hospital clinic attendances and hospitalization episodes from randomization to 18 months of follow-up. Costs will be attributed to the need for: 1. additional invasive or noninvasive imaging, 2. drug therapy, 3. coronary revascularization and 4. hospitalization for chest pain.

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Georgios Rampidis, MD, MSc
  • Phone Number: +30 2310994830
  • Email: grampidi@auth.gr

Study Locations

  • Greece
      • Athens, Greece
        • Lefkos Stavros The Athens Clinic
        • Contact:
          • Georgios Benetos, MD, PhD
      • Athens, Greece
        • National and Kapodistrian University of Athens, School of Medicine
        • Contact:
          • Georgios Benetos, MD, PhD
        • Sub-Investigator:
          • Georgios Benetos, MD, PhD
        • Principal Investigator:
          • Konstantina Aggeli, Prof. in Cardiology
        • Sub-Investigator:
          • Vasiliki Katsi, MD, PhD
      • Thessaloníki, Greece
        • Aristotle University of Thessaloniki, School of Medicine
        • Principal Investigator:
          • Haralambos Karvounis, MD, PhD
        • Sub-Investigator:
          • Olga Deda, PhD
        • Contact:
          • Georgios Rampidis, MD, MSc
        • Sub-Investigator:
          • Georgios Giannakoulas, MD, PhD
        • Sub-Investigator:
          • Periklis Kounatiadis, MD, PhD
        • Sub-Investigator:
          • Panagiotis Bamidis, PhD
        • Sub-Investigator:
          • Antonios Billis, PhD
        • Sub-Investigator:
          • Konstantinos Michailidis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care plus ECG Stress Testing
Participants will be approached and randomized to receive standard care plus ECG-stress testing
No Intervention: Standard of care plus ECG Stress Testing and CACS
Participants will be approached and randomized to receive standard care plus ECG-stress testing and coronary artery calcium scoring
Active Comparator: Standard of care plus CCTA
Participants will be approached and randomized to receive standard care plus ≥ 64 multidetector coronary computed tomography angiography
Diagnostic test: CCTA
Coronary Computed Tomography Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events (MACE)
Time Frame: 18 months
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
Time Frame: 18 months
Frequency (%) of chest-pain rehospitalization
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of angina [Seattle Angina Questionnaire (SAQ)]
Time Frame: 6 months
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Scores range from 0 to 100, where higher scores indicate better function (less physical limitation, less angina and better quality of life)
6 months
Frequency of angina [Seattle Angina Questionnaire (SAQ)]
Time Frame: 12 months
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Scores range from 0 to 100, where higher scores indicate better function (less physical limitation, less angina and better quality of life)
12 months
Frequency of angina [Seattle Angina Questionnaire (SAQ)]
Time Frame: 18 months
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Scores range from 0 to 100, where higher scores indicate better function (less physical limitation, less angina and better quality of life)
18 months
Generic health status [Medical Outcomes Study 12-Item Short Form (SF-12)]
Time Frame: 12 months
The Medical Outcomes Study 12-Item Short Form (SF-12) is a general health questionnaire and is computed using the scores of 12 questions ranging from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

National and Kapodistrian University of Athens
Lefkos Stavros The Athens Clinic

Investigators

  • Study Chair: Haralambos Karvounis, Prof. in Cardiology, Aristotle University of Thessaloniki, School of Medicine
  • Study Director: Georgios Giannakoulas, Prof. in Cardiology, Aristotle University of Thessaloniki, School of Medicine
  • Principal Investigator: Periklis Kounatiadis, MD, PhD, Aristotle University of Thessaloniki, School of Medicine
  • Principal Investigator: Panagiotis Bamidis, Prof. in Bioinformatics, Aristotle University of Thessaloniki, School of Medicine
  • Principal Investigator: Georgios Rampidis, MD, MSc, Aristotle University of Thessaloniki, School of Medicine
  • Principal Investigator: Olga Deda, PhD, Aristotle University of Thessaloniki, School of Medicine
  • Principal Investigator: Antonios Billis, PhD, Aristotle University of Thessaloniki, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

June 6, 2020

First Submitted That Met QC Criteria

June 6, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DATASET PRECISE_01062020_03448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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