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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: Corus CAD (ASGES)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Corus CAD (ASGES) Post-metformin<br>Corus CAD (ASGES) second sample draw results to compare to Corus CAD (ASGES) first draw results (per patient). | Diagnostic Test: Corus CAD (ASGES)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metformin effect on Corus CAD | Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results | 7 days (+7days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corus CAD, ASGES, Age/Sex/Gene Expression Score, Gene Expression, GES, CAD, CVD, CHD, Precision Medicine, Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Disease, Coronary Heart Disease, Metformin