- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07515807
Qatar Cardiometabolic Retrospective Cohort-Analysis Using Artificial Intelligence (QCRC-AI)
Study Overview
Status
Detailed Description
This study combines retrospective and prospective designs.
Retrospective:
We use past electronic medical records to identify participants and collect baseline information from their initial visit (using their code or health card number).
Prospective:
From that starting point, we follow the same participants forward in time, updating data every two years and recording new outcomes (mortality, cardiovascular events, rehospitalizations, treatment-related outcomes) at planned checkpoints (approximately 6 months, 1 year, and 2 years).
New eligible participants identified in later data extractions are added and followed in the same manner. Because we only observe and record participants existing records and outcomes without assigning interventions, the study is observational.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Charbel Abi Khalil Prof
- Phone Number: + 974 4492 8484
- Email: cha2022@qatar-med.cornell.edu
Study Locations
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-
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Doha, Qatar
- Hamad Medical Corporation
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Contact:
- Nidal Asaad MD
- Phone Number: +974 44390220
- Email: nasaad@hamad.qa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18
- Qatari and Arab participants
- Participants admitted for Acute Coronary Syndrome (ACS) or Acute Heart Failure (AHF)
- Metabolic disease: Diabetes (HbA1C ≥ 6.5% or any HbA1C if a patient is on an antidiabetic agent) or pre-diabetes: 5.7% ≤ HbA1c ≤ 6.4%
Exclusion Criteria:
- Non-Qatari or non-Arab participants
- Non-diabetic: HbA1C < 5.7%
- This chart review involves no direct interaction with individuals. Prisoners are not a focus of this study, and incarceration status is not identifiable in the records reviewed.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of 3-point Major Adverse Cardiovascular Events (MACE) in Acute Coronary Syndrome Patients
Time Frame: 5 years
|
Composite endpoint defined as the occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
Events will be identified using electronic medical records, hospital admission data, and follow-up assessments during the study period.
These outcomes will serve as endpoints for the development and validation of predictive machine learning models.
|
5 years
|
|
Incidences of 2-point Major Adverse Cardiovascular Events (MACE) in Heart Failure Patients
Time Frame: 5 years
|
Composite endpoint defined as cardiovascular death or hospitalization for heart failure.
Events will be ascertained through hospital records, clinical documentation, and follow-up data collection.
These outcomes will be used as endpoints for predictive model development and validation.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coronary revascularization
Time Frame: 5 years
|
5 years
|
|
|
Major Adverse Cardiovascular Events
Time Frame: 5 years
|
MACE - Major Adverse Cardiovascular Events
|
5 years
|
|
Unstable angina requiring hospitalization
Time Frame: 5 years
|
5 years
|
|
|
Arrhythmic events
Time Frame: 5 years
|
5 years
|
|
|
Post-Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) complications (stent/graft thrombosis or repeat revascularization)
Time Frame: 5 years
|
5 years
|
|
|
Development or progression of valvular heart disease (aortic or mitral stenosis/regurgitation)
Time Frame: 5 years
|
5 years
|
|
|
New-onset diabetes mellitus
Time Frame: 5 years
|
5 years
|
|
|
Change in glycated Hemoglobin A1c (HbA1c)
Time Frame: 5 years
|
5 years
|
|
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Newly diagnosed medical or surgical conditions not present at baseline
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Charbel Abi Khalil, Weill Cornell Medicine-Qatar
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-00019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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