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

NCT ID: NCT02440893

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-06-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Corus CAD (ASGES) Post-metformin

Corus CAD (ASGES) second sample draw results to compare to Corus CAD (ASGES) first draw results (per patient).

Corus CAD (ASGES)

Intervention Type: DIAGNOSTIC_TEST

Interventions

Corus CAD (ASGES)

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioDx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Mouton, MD

Role: PRINCIPAL_INVESTIGATOR

The Mouton Clinic

Other Identifiers

MET Study

Identifier Type: OTHER

Identifier Source: secondary_id

CDX_000018

Identifier Type: -

Identifier Source: org_study_id