Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary Occlusion and Ventricular Dysfunction, Previously Revascularized.

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Fundación Pública Andaluza Progreso y Salud
Sponsor:
Collaborator:
Iniciativa Andaluza en Terapias Avanzadas
Information provided by (Responsible Party):
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT02022514
First received: December 20, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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 Intervention Phase
Coronary Atherosclerosis and Other Heart Disease
Other: Mononuclear cells from autologous bone marrow
Drug: Conventional medical treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III 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.

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of NYHA functional grade comparative manner between the groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Possible cardiac events during follow-up (death, myocardial infarction, repeat revascularization). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Need for hospital admission or presence of major arrhythmia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in global and segmental left ventricular function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: November 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Conventional medical treatment

Detailed Description:

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:

  1. To design, in view of the results obtained, a more appropriate treatment protocol for chronic coronary occlusion.
  2. To study changes in functional class (I-IV NYHA) of these patients compared with the control group.
  3. 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.
  4. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of both sexes with atherosclerotic coronary artery disease and chronic occlusions of more than 3 months that recanalization has been achieved successfully implanted medicated stents, and in which nevertheless persists ventricular dysfunction.
  2. Aged between 18 and 80 years.
  3. The basal ventricular function recanalization catheterization (performed approximately 3 months before) to less than 45% ejection fraction.
  4. Magnetic resonance performed at least 3 months of recanalization, the ejection fraction patient should remain below 45%.
  5. Normal renal function or mild renal insufficiency with serum creatinine exceeding 2.5 mg / dl.
  6. Normal hepatic transaminases values function within the normal range.
  7. Hemogram and coagulation studies were within normal values. They may include patients with chronic anemia with hemoglobin> 10g/dL.
  8. Blood pregnancy test with negative results in the case of patients of childbearing age.
  9. Acceptance by patients (both men and women) of childbearing age to use safe contraceptive methods throughout the study, including the six month follow-up.
  10. Being able to refrain from taking prohibited drugs, prescription or over the counter, during the treatment phase of the study.
  11. Willingness and ability to implement the program of visits, treatment plan, laboratory tests, and all study procedures.

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022514

Contacts
Contact: Ana Cardesa 0034 955014090 ana.cardesa@juntadeandalucia.es

Locations
Spain
Hospital U. Reina Sofía Recruiting
Sevilla, Spain, 14004
Contact: Manuel Pan Álvarez-Ossorio         
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Iniciativa Andaluza en Terapias Avanzadas
Investigators
Principal Investigator: Mauel Pan Álvarez-Ossorio, MD, PhD Hospital Universitario Reina Sofía
  More Information

Additional Information:
No publications provided

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02022514     History of Changes
Other Study ID Numbers: CMMo/OCC/2012
Study First Received: December 20, 2013
Last Updated: December 20, 2013
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Coronary Occlusion
Heart Diseases
Myocardial Ischemia
Ventricular Dysfunction
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014