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

Coronary Artery Disease Clinical Trial

— DMCAD  

Official title:

Incidence, Characteristics and Outcome of Patients With New Diabetes Mellitus and Pre-Diabetes With First-time Diagnosed Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05208424
• Other study ID #: IRB-2020-02
• Status: Completed
• Start date: February 27, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Saud Al Babtain Cardiac Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 30, 2022
• Est. primary completion date: July 30, 2022
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Diabetes Mellitus
• Myocardial Ischemia
• PreDiabetes
• Prediabetic State

Intervention

Diagnostic Test:
• Coronary angiography
Invasive coronary angiography

Locations

Country	Name	City	State
Saudi Arabia	Saud AlBabtain Cardiac Center	Dammam

Sponsors (1)

Lead Sponsor	Collaborator
Saud Al Babtain Cardiac Center

Country where clinical trial is conducted

Saudi Arabia, 

References & 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. Review. Erratum in: Diabetes Care. 2021 Sep;44(9):2182. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.