Angina Pectoris, CAD, Cardiovascular Diseases, CHD, Chest Pain, Coronary Artery Disease, Coronary Heart Disease, CVD
Conditions
Keywords
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
Brief 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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTCorus CAD (ASGES)
Sponsors
CardioDx
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metformin effect on Corus CAD | 7 days (+7days) | Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results |
Outcome results
None listed