Last updated: March 29, 2023
Sponsor: University Hospital, Toulouse
Overall Status: Completed
Phase
2
Condition
Chest Pain
Myocardial Ischemia
Occlusions
Treatment
N/AClinical Study ID
NCT02462330
10 142 01
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient who signed the informed consent,
- Chronic stable ischemic cardiomyopathy for at least one month with a NYHA Class II-IVand/or -Angina pectoris CCS Class III or IV,
- Not a candidate for revascularization by coronary artery by-pass surgery orangioplasty,
- Left ventricular function ≤45%,
- Presence of ischemia or myocardial viability on the myocardial perfusion imaging,
- VO2 max≤ 20 ml/min/kg,
- Optimal medical therapy,
- Optimal interventional therapy (Implantable Cardiovertor Defibrillator, effortrehabilitation).
Exclusion
Exclusion criteria:
- Pregnancy or breastfeeding,
- Acute coronary syndrome or myocardial infarction during the last 3 months,
- Revascularization (PCI or CABG), or cardiac resynchronization during the last 3months,
- Further revascularization planned for the next 30 days,
- LVEF >45%,
- Left intraventricular Thrombus and / or ventricular aneurysm detected by transthoracicechocardiography,
- Wall thickness in the target region <8 mm as determined by echocardiography,
- Critical Limb Ischemia stages 3 or 4,
- Inability to achieve a VO2 test,
- Not feasible peripheral arterial access for percutaneous procedure,
- Aortic stenosis (<1cm²) or aortic insufficiency (> 2 +),
- Patients with transplanted organ,
- Chronic renal failure with creatinemia ≥ 250 µmol/L,
- Severe hepatic dysfunction,
- Chronic atrial fibrillation,
- Decompensated heart failure,
- Uncontrolled Ventricular arrhythmias,
- Indication of cardiac resynchronization by multisite pacemaker or cardiacresynchronization during the last 3 months,
- Obesity preventing bone marrow aspiration or manual compression of the puncture areaafter bone marrow collection,
- Active uncontrolled infection
- Immuno-modulator treatment (ciclosporin, mycophenolate, mycophenolate mofetil,azathioprine, tacrolimus, anthracyclines, neupogen, hydrea, etanercept interferons,prednisolone, methylprednisolone, colchicine),
- History of cancer in the last 5 years,
- Hemopathy, hematopoietic disease,
- Haemorrhagic syndrome,
- Chronic or progressive disease that may alter the prognosis within 3 months,
- Positive serologies for Human immunodeficiency virus (HIV1-2), HTLV-1 (human T-celllymphotrophic virus) and 2, HBV (hepatitis B virus) or HCV (hepatitis B virus).
- Allergic to xylocain.
Study Design
Total Participants: 39
Study Start date:
February 19, 2016
Estimated Completion Date:
December 19, 2022
Study Description
Connect with a study center
University hospital of Henri Mondor
Créteil, 94010
FranceSite Not Available
University hospital of Grenoble
Grenoble, 38043
FranceSite Not Available
University hospital of Lille
Lille, 59037
FranceSite Not Available
University hospital of Nantes
Nantes, 44093
FranceSite Not Available
University hospital of Pitié-Salpêtrière
Paris, 75651
FranceSite Not Available
Cardiology Department of Rangueil Hospital - Rangueil Hospital
Toulouse, 31059
FranceSite Not Available

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