Coronary Artery DiseaseMETNCT02440893
Understanding the Effect of Metformin on Corus CAD (or ASGES)
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris, Chest Pain
- What is being tested?
- Corus CAD (ASGES)
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
About this study
Official title: Understanding the Effect of Metformin on Corus CAD (MET Study)
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.
Read the 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
- Being tested
- Corus CAD (ASGES)
- 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
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corus CAD (ASGES)Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Corus CAD (ASGES) Post-metformin | Corus CAD (ASGES) second sample draw results to compare to Corus CAD (ASGES) first draw results (per patient). Receives: Diagnostic Test: Corus CAD (ASGES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metformin effect on Corus CAD
Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results
Measured: 7 days (+7days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Mouton, MD, Principal investigator, The Mouton Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440893
- Sponsor's protocol ID
- CDX_000018
- Other IDs
- MET Study
- Acronym
- MET
- Status last verified
- Jan 2019
- First submitted
- 6 May 2015
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Effect of Metformin on Corus CAD (MET Study)
- ClinicalTrials.gov ID
- NCT02440893
- Acronym / sponsor ID
- MET / CDX_000018
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases, Coronary Heart Disease, CAD
- Keywords
- Corus CAD, ASGES, Age/Sex/Gene Expression Score, Gene Expression, GES, CAD, CVD, CHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corus CAD (ASGES) Post-metformin | – | Diagnostic Test: Corus CAD (ASGES)Corus CAD (ASGES) second sample draw results to compare to Corus CAD (ASGES) first draw results (per patient). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- At least 21 years of age
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corus CAD (ASGES) | Diagnostic test | Corus CAD (ASGES) Post-metformin |
Primary outcome
Metformin effect on Corus CAD
Time frame: 7 days (+7days)
Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Mouton, MD principal investigator
The Mouton Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Angina Pectoris, run by CardioDx.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metformin effect on Corus CAD (time frame: 7 days (+7days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.