Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)
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ClinicalTrials.gov Identifier: NCT00203203 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Results First Posted : January 30, 2013
Last Update Posted : November 28, 2016
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Condition or disease | Intervention/treatment | Phase |
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Ischemic Cardiomyopathy | Device: Intramyocardial Injection of stem cells via NOGA Mapping Other: Control, then Stem Cell Therapy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Single Blind Trial of Autologous Bone Marrow Mononuclear Cells Under Electromechanical Guidance for Therapeutic Angiogenesis |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | November 2009 |

Arm | Intervention/treatment |
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Experimental: Stem Cell Therapy
Subject is randomized to receive Stem Cell Therapy (intramyocardial injection of stem cells) via NOGA mapping.
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Device: Intramyocardial Injection of stem cells via NOGA Mapping
Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol.
Other Name: NOGA Star catheter and Myostar Injection. |
Control, then Stem Cell Therapy
Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. |
Other: Control, then Stem Cell Therapy
Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months.
Other Name: cross-over |
- Safety of Autologous-bone-marrow Injections [ Time Frame: up to 2 weeks post-procedure, 3 months and 6 months ]Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).
- Canadian Cardiovascular (CCS) Angina Score [ Time Frame: baseline, 3 months and 6 months ]
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).
Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)
- New York Heart Association (NYHA)Classification [ Time Frame: baseline, 3 months and 6 months ]
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.
Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)
- Myocardial Oxygen Consumption (MVO2) [ Time Frame: baseline, 3 months and 6 months ]Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.
- Echocardiography (EF)Percent (%) [ Time Frame: baseline, 3 months and 6 months ]Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.
- Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) [ Time Frame: baseline and 3 months ]Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25.
- Echocardiography Wall Motion Score Index (WMSI) [ Time Frame: baseline and 3 months ]Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.
- Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) [ Time Frame: baseline, 3 months and 6 months ]Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction.
- Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) [ Time Frame: baseline and 6 months ]Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the "gold" standard.
- Left Ventricular End-Diastolic Volume (LVEDV) [ Time Frame: baseline, 3 months and 6 months ]Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.
- Left Ventricular End-Systolic Volume (LVESV) (ml) [ Time Frame: baseline, 3 months and 6 months ]Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV)when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.
- Endocardial Unipolar Voltages (UPV) [ Time Frame: baseline and 6 months ]Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is <5.5 mV.
- Linear Local Shortening (LLS) [ Time Frame: baseline and 6 months ]Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- LVEF less than 45%
- Functional class III or IV angina
- At least 7% reversibility by Single Photon Emission Computed Tomography (SPECT) nuclear study
- there are additional inc. criteria
Exclusion Criteria:
- AGe <18 or >70 years of age
- Constant atrial fibrillation
- Left ventricular (LV) thrombus
- History of malignancy in the last 5 years
- LV wall thickness of < 8 mm at the target site
- there are additional exclusion criteria

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): NCT00203203
United States, Texas | |
Texas Heart Institute/Baylor St. Luke's Medical Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Emerson Perin, MD,PhD. | Texas Heart Institute/Baylor St Luke's Medical Center |
Publications of Results:
Responsible Party: | Emerson Perin, MD, PhD, Director Clinical Research for Cardiovascular Medicine and Director Stem Cell Center, Texas Heart Institute |
ClinicalTrials.gov Identifier: | NCT00203203 |
Other Study ID Numbers: |
HSC-MS-04-141 |
First Posted: | September 20, 2005 Key Record Dates |
Results First Posted: | January 30, 2013 |
Last Update Posted: | November 28, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Data summarized and published. No need to share individual patient data. |
Autologous Cardiac Stem Cell Transplant |
Cardiomyopathies Heart Diseases Cardiovascular Diseases |