Cell Therapy in Diabetic Patients With ST-Segment Elevation Myocardial Infarction(STEMI)
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|ClinicalTrials.gov Identifier: NCT01307371|
Recruitment Status : Unknown
Verified February 2011 by Xijing Hospital.
Recruitment status was: Recruiting
First Posted : March 2, 2011
Last Update Posted : March 2, 2011
|Condition or disease||Phase|
|Left Ventricular Function Systolic Dysfunction Left Ventricular Function Diastolic Dysfunction Death Myocardial Reperfusion Injury||Phase 1|
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|Observational Model:||Case Control|
|Official Title:||Effects and Mechanism of Autologous Bone Marrow Mononuclear Cells (BMMNC)Transplantation in Diabetic Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Who Have Undergone Percutaneous Coronary Intervention (PCI)|
|Study Start Date :||March 2007|
|Primary Completion Date :||March 2008|
|Estimated Study Completion Date :||December 2011|
Patients with diabetes.
Patients without diabetes.
- Number of patient death during the follow up period [ Time Frame: 4years ]Number of patient death during the follow up period as a measure of safety
- Left ventricular ejection fraction [ Time Frame: 4 years ]Left ventricular ejection fraction as evaluated by echocardiography and SPECT
- Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT) [ Time Frame: 4 years ]
- Infarct size as evaluated by Single-photon emission computed tomography (SPECT) [ Time Frame: 4 years ]
- Number of target vessel revascularization [ Time Frame: 4 years ]Number of target vessel revascularization during the follow up period
- Angina class according to the canadian cardiovascular society (CCS) classification [ Time Frame: 4 years ]
- Scores on the Seattle angina questionnaire [ Time Frame: 4 years ]
- six-min walk distance (6MWD) [ Time Frame: 4 years ]Quality of life as evaluated by 6-min walk distance
Biospecimen Retention: Samples With DNA
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): NCT01307371
|Xi'an, Shaanxi, China, 710032|
|Contact: Dongdong Sun, MD, PhD 86 29 84775183 email@example.com|
|Principal Investigator:||Feng Cao, MD, PhD||Fourth Military Medical University|