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

NCT02440893 | Completed

• 2 other identifiers: CDX_000018MET Study
• Study Type: observational
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Metformin effect on Corus CAD

  Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results

  7 days (+7days)

Study Arms (1)

Corus CAD (ASGES) Post-metformin

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

Diagnostic Test: Corus CAD (ASGES)

Interventions

Corus CAD (ASGES) DIAGNOSTIC_TEST

Corus CAD (ASGES) Post-metformin

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CardioDx: lead

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Diseases; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Mouton, MD

  The Mouton Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 12, 2015
• Study Start: September 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 31, 2019

Record last verified: 2019-01