Clinical trial NCT02440893: Understanding the Effect of Metformin on Corus CAD (or ASGES)
Official title: Understanding the Effect of Metformin on Corus CAD (MET Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Angina Pectoris
Chest Pain
Cardiovascular Diseases
Coronary Heart Disease
CAD
CVD
CHD
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
Lead sponsor: CardioDx
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be enrolled from participating sites as applicable inclusion/exclusion criteria are met. The study aims to enroll approximately fifty (50) patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metformin effect on Corus CAD
timeFrame: 7 days (+7days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Mouton Clinic
name: Mark Mouton, MD
role: PRINCIPAL_INVESTIGATOR
References: