NCT05208424

Brief Summary

A prospective analytic study to evaluate the incidence, clinical and laboratory characteristics, extent of coronary artery disease and short-term outcome of newly diagnosed diabetes and pre-diabetes in patients with first-time diagnosed coronary artery disease treated in Saud Al Babtain Cardiac Center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 27, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

December 23, 2021

Last Update Submit

October 25, 2022

Conditions

PreDiabetesDiabetesCoronary Artery Disease

Outcome Measures

Primary Outcomes (4)

  • Incidence

    The incidence, number and percent, of newly diagnosed diabetes and pre-diabetes in patients with first-time diagnosed coronary artery disease

    Through study completion, an average of 2 year

  • Characteristics, clinical and laboratory

    Clinical and laboratory characteristics of newly diagnosed diabetes and pre-diabetes in Patients with first-time diagnosed coronary artery disease.

    Through study completion, an average of 2 year

  • Coronary artery disease severity

    Extent of newly diagnosed coronary artery disease in newly diagnosed diabetes and pre-diabetes. The severity of coronary artery disease will be assessed using the SYNTAX score.

    Through study completion, an average of 2 year

  • Short-term outcome

    Assessment will include in-hospital and 1-month major adverse cardiac events (MACE), recurrent angina, stent thrombosis, need for emergent/urgent coronary intervention, clinical heart failure and left ventricular dysfunction.

    From admission to 1-month follow up.

Study Arms (3)

Normal glycemia

100 patients without evidence of dysglycemia.

Diagnostic Test: Coronary angiography

Prediabetes

100 patients with evidence of pre-diabetes defined as hemoglobin A1C (HbA1c) 5.7-6.4% with or without fasting plasma glucose (FPG) of 100 mg/dL to 125 mg/dL.

Diagnostic Test: Coronary angiography

Diabetes

100 patients without evidence diabetes defined as hemoglobin HbA1c \> 6.4% with or without FPG \>125 mg/dL.

Diagnostic Test: Coronary angiography

Interventions

Coronary angiographyDIAGNOSTIC_TEST

Invasive coronary angiography

DiabetesNormal glycemiaPrediabetes

Eligibility Criteria

Age18 Months+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients with first time diagnosed coronary artery disease, based on invasive coronary angiography, with no prior history of dysglycemia will be enrolled from all comers to Saud AlBabtain Cardiac Center

You may qualify if:

  • First time diagnosed coronary artery disease as confirmed by invasive coronary angiography
  • Emergently or electively admitted as coronary artery disease patients.
  • Informed consent form

You may not qualify if:

  • Prior diagnosis of diabetes or pre-diabetes based on the diagnostic criteria of the American Diabetes Association (ADA, 2020)
  • Known coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saud AlBabtain Cardiac Center

Dammam, Saudi Arabia

Location

Related Publications (2)

  • American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S15-S33. doi: 10.2337/dc21-S002.

    PMID: 33298413BACKGROUND

  • Zhang YJ, Iqbal J, Campos CM, Klaveren DV, Bourantas CV, Dawkins KD, Banning AP, Escaned J, de Vries T, Morel MA, Farooq V, Onuma Y, Garcia-Garcia HM, Stone GW, Steyerberg EW, Mohr FW, Serruys PW. Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: insights from the SYNTAX trial. J Am Coll Cardiol. 2014 Aug 5;64(5):423-32. doi: 10.1016/j.jacc.2014.05.022.

    PMID: 25082573BACKGROUND

MeSH Terms

Conditions

Prediabetic StateDiabetes MellitusCoronary Artery Disease

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularHeart Function Tests

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 26, 2022

Study Start

February 27, 2020

Primary Completion

July 30, 2022

Study Completion

September 30, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)