NCT07515807

Brief Summary

Cardiovascular disease is the leading cause of death worldwide, and individuals with diabetes or other cardiometabolic conditions are at increased risk of adverse cardiovascular outcomes. Although advances in prevention and treatment have reduced cardiovascular events globally, cardiometabolic disease continues to represent a significant health burden, particularly in regions with high diabetes prevalence. In Qatar and other Gulf Cooperation Council countries, the prevalence of diabetes and obesity is increasing, contributing to a high proportion of participants presenting with acute coronary syndrome who have type 2 diabetes or prediabetes. This observational study will use electronic medical record data from patients hospitalized at the Heart Hospital with acute coronary syndrome and a concomitant diagnosis of diabetes or prediabetes. The study will assess trends in cardiovascular risk factors and cardiovascular events, including readmission and mortality. An artificial intelligence component will be used to develop and validate machine learning based risk prediction models to forecast adverse cardiovascular outcomes in participants with cardiometabolic disease. These models will integrate clinical, biochemical, imaging, and other non-invasive data routinely collected during participants care to identify predictors of cardiovascular events.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Jul 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 16, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2030

Last Updated

April 21, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

March 31, 2026

Last Update Submit

April 15, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of 3-point Major Adverse Cardiovascular Events (MACE) in Acute Coronary Syndrome Patients

    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

    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 Outcomes (9)

  • Major Adverse Cardiovascular Events

    5 years

  • Unstable angina requiring hospitalization

    5 years

  • Arrhythmic events

    5 years

  • Coronary revascularization

    5 years

  • Post-Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) complications (stent/graft thrombosis or repeat revascularization)

    5 years

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants admitted at Hamad Medical Corporation for Acute Coronary Syndrome (ACS) or Acute Heart Failure (AHF).

You may qualify if:

  • 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%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

MeSH Terms

Conditions

Acute Coronary SyndromeDiabetes Mellitus, Type 2Glucose Intolerance

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Charbel Abi Khalil

    Weill Cornell Medicine-Qatar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charbel Abi Khalil Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start (Estimated)

July 16, 2026

Primary Completion (Estimated)

July 16, 2030

Study Completion (Estimated)

July 16, 2030

Last Updated

April 21, 2026

Record last verified: 2026-03

Locations