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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT01049867
Eligibility Criteria:
Inclusion Criteria:
* Patients with proven CHD by coronary angiography demonstrating occlusion or extreme stenosis (\> 90%) of a coronary artery (target artery) not suitable for angioplasty or surgery.
* Angiographic criteria: Feasibility for balloon catheter placement without risks of obstruction of the left main coronary trunk.
* Evidence of viable myocardial tissue in the area irrigated by the target artery by MRI (low dose dobutamine and late enhancement).
* CCS class 2-4 angina pectoris (angina pectoris at rest and at light exertion, obvious reduction in the exertion capacity).
* Optimal antianginal pharmacologic therapy (consistent with the current guidelines of ACC (American College of Cardiology), as well as the DGK (Deutsche Gesellschaft für Kardiologie)
* Signed written consent form accepted by the Ethics Committee.
* Effective contraception in women of child-bearing age.
Exclusion Criteria:
* Severe symptomatic heart failure (NYHA class 4).
* Myocardial aneurysm (in the target region) without evidence of viable myocardium.
* Myocardial infarction in the last 4 weeks.
* Symptomatic ventricular tachycardia.
* Known malignancy.
* Known hematological disease.
* Renal insufficiency with creatinine \> 2.5 mg/dl.
* Pregnancy.
* Active chronic inflammatory bowel disease or rheumatic disease with high parameters of inflammation (WBCs above 10/nl and increased C-reactive protein). Systemic steroid administration.
* Severe coagulopathy or phenprocoumon type anticoagulation therapy at the time of bone marrow extraction.
* Antiproliferative therapy (chemotherapy, etc.).
* Non accordance with procedures and follow-up studies.
* Contraindications to MRI studies.
* Known hypersensitivity against mouse immunoglobulins.
* Known hypersensitivity against ferridextran.
* Contraindications for bone marrow extraction.
* Cerebrovascular accident in the past four months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01049867
Study Brief:
Protocol Section:
NCT01049867