Stable Angina Clinical Trial
Official title:
A Randomized,Prospective,Double-blind Study to Evaluate Intracardiac Injections of Bone Marrow,Autologous CD133+Cells(Electromechanical Mapping Based)in Patients With Resistant Angina and no Effective Revascularization Option. RegentVsel
The purpose of the study is to evaluate the efficacy of therapy with autological CD133+ cells in patients with angina resistant to pharmacological treatment and without the possibility of effective revascularization. Cells will be isolated from patients bone marrow and administered directly into the muscle of left ventricle. The main objective is to assess the treatments' influence on improvement of myocardial perfusion and function, and on decrease of occurrence of symptomatic angina.
Patients with a Stable angina pectoris (CCS II-IV) can potentially benefit from treatment
with autological CD133+ cell populations, which include cells with a higher expression of
cardiac and endothelial differentiation markers.
REGENT VSEL Trial will include Patients with Angina resistant to pharmacological treatment
and without the possibility of effective revascularization.
The main objective of the study is to assess the treatments influence on:
- improvement of myocardial perfusion
- global and segmental contractility (LVEF)
- occurrence of symptomatic angina
- quality of life
Regent Vsel is a prospective, randomized, double blind, placebo-controlled study with a
planned number of 60 Patients.
Randomization will be carried out according to a 1:1 mode. Every Patient will undergo a bone
marrow aspiration. CD133+ cells will be isolated from bone marrow aspirates. Patients
randomized to experimental group will receive isolated cells (direct left ventricular muscle
administration). Patients enrolled to control group will get only a placebo solution injected
into the muscle.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02892903 -
In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes?
|
N/A | |
| Not yet recruiting |
NCT02871622 -
BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
|
N/A | |
| Completed |
NCT02252406 -
Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome
|
Phase 4 | |
| Not yet recruiting |
NCT02550301 -
Does Mean Platelet Volume Change With Clopidogrel
|
N/A | |
| Active, not recruiting |
NCT02244853 -
Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease
|
N/A | |
| Not yet recruiting |
NCT01162902 -
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
|
Phase 4 | |
| Completed |
NCT01826552 -
Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent
|
Phase 4 | |
| Completed |
NCT02126150 -
United Coronary Biobanks
|
N/A | |
| Completed |
NCT01328470 -
Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT01769079 -
Clinical Impact of the Withdrawal of Nitrate in Patients With Stable Angina
|
Phase 4 | |
| Unknown status |
NCT00751491 -
Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI)
|
Phase 3 | |
| Completed |
NCT00263263 -
RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.
|
Phase 2 | |
| Active, not recruiting |
NCT04929496 -
Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study
|
N/A | |
| Completed |
NCT03103620 -
Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
|
||
| Recruiting |
NCT05459051 -
Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
|
||
| Completed |
NCT06464276 -
Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Study
|
||
| Not yet recruiting |
NCT04403048 -
Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID
|
N/A | |
| Completed |
NCT01974492 -
Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting
|
N/A | |
| Completed |
NCT01990924 -
Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention
|
N/A | |
| Completed |
NCT02120859 -
Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty
|
Phase 4 |