Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT02887768
Eligibility Criteria:
Inclusion Criteria:
* The patient has been diagnosed with an acute STEMI or NSTEMI (confirmed by ST changes on serial ECG, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography)
* The patient is scheduled to undergo coronary artery bypass surgery within 6 weeks of the acute event.
* The patient does not possess any contraindication for CMR.
* The patient is greater then 35-years of age, English speaking, and capable of giving informed consent.
* The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.
Exclusion Criteria:
* The patient is over the age of 75 years.
* The patient has previous MI (other than the qualifying event) and/or has scar or non-viable myocardium identified by CMR in any other LV territory.
* The patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery).
* The patient requires emergency surgery (i.e. operative intervention (CABG or ventricular assist device) within 24-hrs of assessment).
* The patient has undergone previous cardiac surgery.
* The patient's postsurgical life expectancy is less than 45 days, in the investigator's opinion.
* The patient is of excessively poor baseline health, health-related quality of life, or physical functioning that would preclude a reasonable expected post-operative recovery.
* The patient has received radiotherapy to the chest wall, is receiving immunosuppressive therapy, or is in any way immunocompromised.
* The patient has a history of malignancy within the past year (other than squamous or basal cell carcinoma, which has been treated without evidence of recurrence).
* The patient has a recent history of drug or alcohol abuse.
* The patient has within 30-days of enrollment or is at anytime during this study participating in any other drug or device study.
* The patient has a known allergy to the CorMatrix-ECM material or any component of the material.
* Absence of non-viable myocardium within the LV on CMR.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT02887768
Study Brief:
Protocol Section:
NCT02887768