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

Completed

• Conditions: Coronary Artery Disease; Chest Pain; Coronary Heart Disease; CAD; Angina Pectoris; Cardiovascular Diseases; CVD; CHD
• Interventions: Diagnostic Test: Corus CAD (ASGES)

• Registration Number: NCT02440893
• Lead Sponsor: CardioDx

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.

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Corus CAD (ASGES) Post-metformin	Corus CAD (ASGES)	Corus CAD (ASGES) second sample draw results to compare to Corus CAD (ASGES) first draw results (per patient).

Primary Outcome Measures

Name	Time	Method
Metformin effect on Corus CAD	7 days (+7days)	Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results