Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary Occlusion and Ventricular Dysfunction, Previously Revascularized.
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|ClinicalTrials.gov Identifier: NCT02022514|
Recruitment Status : Recruiting
First Posted : December 27, 2013
Last Update Posted : April 17, 2018
Clinical trial phase III, prospective, controlled, randomized, open.
We hypothesize work that patients with chronic coronary occlusion and poor myocardial viability who failed to recover ventricular function after subjecting coronary revascularization with new techniques of recanalization, could achieve an improvement of ventricular function if given further regenerative treatment with mononuclear cells from autologous bone marrow.
To test this hypothesis we designed a prospective, randomized clinical trial in patients with recanalized chronic occlusions and ventricular dysfunction.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Atherosclerosis and Other Heart Disease||Other: Mononuclear cells from autologous bone marrow Drug: Conventional medical treatment||Phase 2 Phase 3|
This is a randomized, open label prospective clinical trial in which all patients diagnosed with chronic coronary occlusion in the Cardiology Department of Hospital Reina Sofía de Córdoba, who meet inclusion criteria and none of the exclusion shall include and express their accordance with trial participation by signing the informed consent.
66 patients who did not improve ventricular function measured by Magnetic resonance at least 3 months after revascularization of chronic coronary occlusion will be included . The 66 patients will be randomized in one to one ratio to an intervention group that received bone marrow mononuclear cells by intracoronary autologous (0.5 to 1 x 10 9 total cells) and a control group who receive only conventional medical treatment. The two groups of patients will be followed, in the clinical trial, for 6 months. Once the test is complete, they will follow according to standard clinical practice of Cardiology hospital for at least 24 months.
Patients will be assessed by clinical echocardiographic and Magnetic resonance methods. All patients will be medically treated similarly with ACE inhibitors or angiotensine 1 receptor (AT1) receptor antagonists of angiotensin II, beta-blockers and diuretics.
The main objective os the study is to determine the efficacy of intracoronary infusion of mononuclear cells from autologous bone marrow in patients with chronic coronary occlusion previously revascularized with stents in terms of improved ventricular function determined by magnetic resonance.
Secondary objectives of the study are:
- To confirm, in view of the obtained results, the suitability of the proved protocol for the treatment of chronic coronary occlusion.
- To study changes in functional class (I-IV NYHA) of these patients compared with the control group.
- To evaluate the safety of treatment, the analysis of possible cardiac events during the 6-month follow-up in the clinical trial and 24 months of additional clinical follow-up (death, myocardial infarction, repeat revascularization) compared with the control group.
- To study changes in global and segmental left ventricular function by studying myocardial deformation Speckle tracking echocardiography bidimensional (EST2D) and three-dimensional echocardiography comparatively amongst patients along the track and the two groups.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IIb Clinical Trial, Unicentric, Open, Randomized and Controlled to Assess the Effectiveness of Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary Occlusion and Ventricular Dysfunction, Previously Revascularized.|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: Mononuclear cells from autologous bone marrow
Mononuclear bone marrow cells autologous intracoronary
Other: Mononuclear cells from autologous bone marrow
Mononuclear bone marrow cells autologous intracoronary
Active Comparator: Conventional medical treatment
Conventional medical treatment
Drug: Conventional medical treatment
- The primary endpoint will be the change in ejection fraction measured by magnetic resonance between inclusion and at 6 months follow-up [ Time Frame: 6 months ]
- Changes of NYHA functional grade comparative manner between the groups. [ Time Frame: 6 months ]
- Possible cardiac events during follow-up (death, myocardial infarction, repeat revascularization). [ Time Frame: 6 months ]
- Need for hospital admission or presence of major arrhythmia [ Time Frame: 6 months ]
- Changes in global and segmental left ventricular function [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022514
|Contact: Ana Cardesa||0034 firstname.lastname@example.org|
|Hospital U. Reina Sofía||Recruiting|
|Sevilla, Spain, 14004|
|Contact: Manuel Pan Álvarez-Ossorio|
|Principal Investigator:||Mauel Pan Álvarez-Ossorio, MD, PhD||Hospital Universitario Reina Sofía|