Understanding the Effect of Metformin on Corus CAD (or ASGES)

Coronary Artery Disease Clinical Trial

— MET  

Official title:

Understanding the Effect of Metformin on Corus CAD (MET Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440893
• Other study ID #: CDX_000018
• Secondary ID: MET Study
• Status: Completed
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2019
• Source: CardioDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD (henceforth "Corus") in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken.

Description:

The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken. The primary aim of this study was to evaluate whether metformin used in pre-diabetic patients to prevent progression to type II diabetes had a significant effect on the gene expression levels measured in Corus. This was a prospective study. Subjects were enrolled from participating sites as applicable inclusion/exclusion criteria were met. The study aimed to enroll approximately fifty (50) patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

At least 21 years of age

Any of the following:

• Chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial ischemia

• Low-risk unstable angina, or

• Asymptomatic individuals with a high probability of CAD

Clinician diagnosis of pre-diabetes, per ADA guidelines, such that metformin therapy is prescribed:

• HgA1C: >5.7% - <6.4%,

• BMI> 35 kg/m2

• Age< 60 yrs

• Prior Gestational Diabetes Mellitus

• FPG: >100mg/dl - <126mg/dl

• OGTT: >140mg/dl - <200mg/dl Willingness to comply with metformin therapy, for at least seven (7) days (P.O., per physician's dosage discretion) Willingness to maintain a drug diary for duration of study, for full follow-up period (7 + 7 days) Willingness and ability to provide two (2) samples for Corus (baseline, 7 (+ 7) days post- medication start) Provide written informed consent

Exclusion Criteria:

• History of or current level of HbA1C >6.5

• History of or current prescription of metformin or any other diabetic medication

• History of myocardial infarction (MI) or prior revascularization

• Current MI or acute coronary syndrome (ACS)

• Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms

• Current systemic infectious or systemic inflammatory conditions

• Subjects currently taking steroids, immunosuppressive agents or chemotherapeutic agents

Related Conditions & MeSH terms

• Angina Pectoris
• CAD
• Cardiovascular Diseases
• CHD
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• CVD
• Heart Diseases
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Corus CAD (ASGES)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CardioDx

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metformin effect on Corus CAD	Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results	7 days (+7days)