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:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT02071602
Eligibility Criteria:
Inclusion Criteria:
* Significant chest discomfort and /or shortness of breath
* ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads
* Successful reperfusion therapy (\>TIMI grade 2 flow) either with thrombolytics or any mechanical forms of revascularization, including stent, PTCA, thrombectomy, etc. within 24 hours of onset of symptoms as documented by coronary angiography
* No previously known history of AMI (prior to current cardiac event) or no previous ECG (prior to current cardiac event) suggesting an old AMI (Q wave on presenting ECG is not an exclusion)..
Exclusion Criteria:(Assessed at the time of enrollment unless otherwise stated)
* Cardiogenic shock, acute heart failure or hypotension (Systolic BP \< 90 mmHg)
* Previous known decreased EF \< 40%
* Atrial Fibrillation
* Persistent signs and symptoms of Post MI ischemia
* Requirement of pressors for maintenance of blood pressure.
* Intra-aortic blood pump use
* Significant (moderate-severe) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension.
* Severe congenital heart diseases
* Sustained ventricular tachycardia or ventricular fibrillation
* Second or third degree heart block without a permanent cardiac pacemaker
* Stroke within 3 months or other evidence of significantly compromised CNS perfusion
* Total bilirubin of \> 2.5 mg/dL or other liver enzymes \>2.5 times the upper limit of normal if available clinically and measured within the last 7 days
* Patients with calculated GFR \<30 ml by MDRD equation or those with acute kidney injury as defined by an increase of plasma creatinine of 0.5 mg/dL from a plasma creatinine measured within the last 7 days
* Serum sodium of \< 125 mEq/dL or \> 160 mEq/dL if available clinically and measured within the last 7 days
* Serum potassium of \< 3.0 mEq/dL or \> 5.8 mEq/dL if available clinically and measured within the last 7 days
* Hemoglobin \< 8.5 gm/dl if available clinically and measured within the last 7 days
* Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data
* Received an investigational drug within 1 month prior to dosing
* Female subject who is pregnant or breastfeeding
* In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02071602
Study Brief:
Protocol Section:
NCT02071602