Understanding the Effect of Metformin on Corus CAD (MET Study)
| Registry | NCT02440893, acronym MET |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 37 (Actual) |
| Sponsor | CardioDx (Industry) |
| Conditions | Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD, CVD, CHD |
| Interventions | Corus CAD (ASGES) (Diagnostic test) |
| Dates | start 2013-09-01, primary completion 2014-06-01, completion 2014-06-01, first posted 2015-05-12, last updated 2019-01-31 |
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All trials for Coronary Artery Disease All trials for Angina Pectoris All trials of Corus CAD (ASGES)
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Corus CAD (ASGES) Post-metformin | Diagnostic Test: Corus CAD (ASGES) | Corus CAD (ASGES) second sample draw results to compare to Corus CAD (ASGES) first draw results (per patient). |
Sex: All, ages: 21 Years to any
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