- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626145
Long Term Follow-up of Autologous Bone Marrow Mononuclear Cells Therapy in STEMI
Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results.
Aim is to evaluate the long term efficiency of unselected bone marrow mononuclear cells in treatment of patients with ST-elevation myocardial infarction (STEMI), especially with regard to the left ventricular function. The cells are delivered by intracoronary infusion 7 days after the PCI. Outcomes including LVEF, myocardial viability and coronary artery status are assessed by echocardiography, SPECT and coronary angiography.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Department of Cardiology in Xijing Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ST segment elevation myocardial infarction, according to the WHO definition.
- <24 hour from the origin of symptoms.
- Single left anterior descending coronary artery disease.
- Successful revascularization of culprit lesion with PCI.
- Age between 45 and 65 years old.
- Written informed consent.
Exclusion Criteria:
- Previous MI.
- Cardiomyopathy.
- Atrial fibrillation or fluctuation.
- Previous heart surgery.
- Severe valvular heart disease.
- Disease of the hematopoetic system.
- NYHA functional class IV at baseline.
- Severe renal, lung and liver disease or cancer.
- Significant coronary lesion in one or more major coronary vessels, requiring revascularization.
- Intra-cardiac thrombus.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Patients receive intracoronary injections of saline 7 days after PCI.
|
Patients receive intracoronary injections of saline 7 days after PCI.
Other Names:
|
Experimental: 2
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
|
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Left Ventricular Ejection Fraction(LVEF)
Time Frame: 1, 3, 6 months, 1, 4 years
|
1, 3, 6 months, 1, 4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
in-stent restenosis
Time Frame: 1, 3, 6 months, 1, 4 years
|
1, 3, 6 months, 1, 4 years
|
cardiac shock
Time Frame: 1, 3, 6 months, 1, 4 years
|
1, 3, 6 months, 1, 4 years
|
myocardial viability of the infarcted area
Time Frame: 1, 3, 6 months, 1, 4 years
|
1, 3, 6 months, 1, 4 years
|
end-diastolic Volume/end-systolic Volume(EDV/ESV)
Time Frame: 1, 3, 6 months, 1, 4 years
|
1, 3, 6 months, 1, 4 years
|
wall motion score index(WMSI)
Time Frame: 1, 3, 6 months, 1, 4 years
|
1, 3, 6 months, 1, 4 years
|
cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization)
Time Frame: 1, 3, 6 months, 1, 4 years
|
1, 3, 6 months, 1, 4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Haichang Wang, MD,PHD, Xijing Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00200301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
Clinical Trials on saline infusion
-
Bispebjerg HospitalPsychiatric Centre RigshospitaletCompletedCognitive Change | Type2 Diabetes | KetonemiaDenmark
-
Yale UniversityWithdrawnOvarian Hyperstimulation SyndromeUnited States
-
Assaf-Harofeh Medical CenterNot yet recruiting
-
University of CalgaryNot yet recruitingPostural Orthostatic Tachycardia Syndrome | Post Acute Sequelae of SARS CoV 2 Infection
-
Icahn School of Medicine at Mount SinaiNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting
-
Rigshospitalet, DenmarkCompleted
-
Göteborg UniversityCompleted
-
University of NottinghamCompleted
-
Universitair Ziekenhuis BrusselCompletedUterine Fibroid | Endometrial CystBelgium
-
University Hospital, LinkoepingSahlgrenska University Hospital, Sweden; University Hospital, Umeå; Region Örebro...CompletedHeart Failure | Postoperative Complications | Coronary Artery Bypass SurgerySweden