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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT03039751
Eligibility Criteria:
Inclusion Criteria:
* informed consent signed
* age \> 30 but \< 85 years
* significant angina pectoris (CCS 2-3) despite of optimal medication
* significant stenosis (\> 60%) in coronary angiography (\< 6 months)
* contraindication to CABG or PCI due to diffuse or distal stenosis, chronic total occlusion, vessels with difficult anatomy, stenosis with severe calcifications and stenosis in small vessels (\<2.5 mm))
* angina pectoris or equivalent symptoms in the 6-minute walking exercise test
* left ventricle wall \> 8 mm detected by transthoracic echocardiography or magnetic resonance imaging (treatment area)
Exclusion Criteria:
* women in fertile age
* diabetes mellitus with severe complications such as diabetic retinopathy or nephropathy
* clinically significant anemia (hemoglobin count \< 120 mg/l in male, \< 110 mg/l in female; hematocrit \< 0.36), leukopenia (b-leukocyte count \< 3.0x109/l), leukocytosis (b-leukocyte count \> 12.0x109/l) or thrombocytopenia (b-thrombocyte count \< 100x109/l)
* renal insufficiency (P-creatinine \> 160 mg/l)
* liver insufficiency (P-alanine aminotransferase or P-alkaline phosphatase over 2 x normal)
* haematuria of unknown origin
* severe hypertension (systolic blood pressure \> 200 mmHg or diastolic blood pressure \> 110 mmHg) or significant hypotension (systolic blood pressure \< 90 mmHg)
* significant obesity (Body Mass Index \> 35)
* acute infection
* immunosuppressive medication
* significant impairment of left ventricular function (ejection fraction \< 25% in echocardiography)
* symptomatic congestive heart failure (New York Heart Association class 3-4)
* haemodynamically significant (grade 3-4/4) aortic or mitral regurgitation or other heart disease needing surgery
* recent (\< 6 weeks) acute coronary syndrome or myocardial infarction, PCI or CABG, stroke or transient ischemic attack (TIA)
* current or suspected malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT03039751
Study Brief:
Protocol Section:
NCT03039751