New Diabetes Mellitus and Pre-Diabetes With First-time Diagnosed Coronary Artery Disease

NCT ID: NCT05208424

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-27

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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PreDiabetes Diabetes Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal glycemia

100 patients without evidence of dysglycemia.

Coronary angiography

Intervention Type DIAGNOSTIC_TEST

Invasive 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.

Coronary angiography

Intervention Type DIAGNOSTIC_TEST

Invasive coronary angiography

Diabetes

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

Coronary angiography

Intervention Type DIAGNOSTIC_TEST

Invasive coronary angiography

Interventions

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Coronary angiography

Invasive coronary angiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saud Al Babtain Cardiac Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saud AlBabtain Cardiac Center

Dammam, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type BACKGROUND
PMID: 33298413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25082573 (View on PubMed)

Other Identifiers

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IRB-2020-02

Identifier Type: -

Identifier Source: org_study_id

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