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

CardioDx

Status: Completed

Conditions: CVD; Coronary Artery Disease; CHD; CAD; Coronary Heart Disease; Chest Pain; Angina Pectoris; Cardiovascular Diseases

Treatments: Diagnostic Test: Corus CAD (ASGES)

Study type: Observational

Funder types: Industry

Identifiers

NCT02440893

MET Study (Other Identifier)

CDX_000018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

37 participants in 1 patient group

Corus CAD (ASGES) Post-metformin

Description:

Corus CAD (ASGES) second sample draw results to compare to Corus CAD (ASGES) first draw results (per patient).

Treatment:

Diagnostic Test: Corus CAD (ASGES)