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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT01555320
Eligibility Criteria:
Inclusion Criteria:
* Age 40 to 79
* Patients with ischemic heart failure：
* LVEF less than or equal to 45% measured by echocardiography in modified Simpson method
* History of prior myocardial infarction with or without percutaneous coronary intervention (PCI) or/and coronary artery bypass grafting (CABG);
* Coronary angiography (CAG) or coronary CTA shows more than or equal to 50% stenosis in at least one of the main coronary arteries with or without revascularization, of which the researcher thinks that it is closely related to heart failure;
* With or without dyspnea, fatigue and fluid retention (edema) etc.
* History of heart failure or present with heart failure symptoms for at least 3 months;
* New York Heart Association (NYHA) Class II to IV;
* Submitted informed consent
Exclusion Criteria:
* Acute heart failure or acute exacerbation of chronic heart failure
* Those who have one of the following diseases:
* Acute coronary syndrome within 30 days
* Revascularization therapy within 6 months
* Uncontrolled hypertension with systolic pressure more than or equal to 180mmHg and/or diastolic pressure more than or equal to 110mmHg
* Second degree type 2 or worse sinoatrial/atrioventricular block without implantation of pacemaker or uncontrolled malignant cardiac arrhythmia
* Dilated cardiomyopathy
* Hypertrophic obstructive cardiomyopathy
* Myocarditis
* Pulmonary artery embolism
* Severe valvular heart disease
* Pulmonary heart disease
* Stroke within 6 months
* Cardiac resynchronization therapy
* Applied diuretics, cardiotonic agents or vasodilators intravenously within 7 days
* Severe endocrine diseases such as hyperthyroidism, etc.
* History of malignant tumor
* Hemoglobin (HB )≤ 9g/dl
* Alanine aminotransferase (ALT) \> 2 times the upper limit of normal
* Serum creatinine \> 265 μmol/L
* Mental disorder
* Being pregnant, planning for pregnancy or breastfeeding
* Suspicious or definite allergy to intervention drugs
* Participated in other trials within 2 months
* Unable to walk autonomously due to physical disabilities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
79 Years
Study:
NCT01555320
Study Brief:
Protocol Section:
NCT01555320