Myocardial Infarction Clinical Trial
— PMIR-miR-126Official title:
Impact of Circulating miR-126 on Left Ventricular Remodeling and Clinical Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention. The PMIR-miR-126 Study.
Verified date | July 2015 |
Source | Qilu Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: National Natural Science Foundation |
Study type | Observational |
Purpose: The purpose of this study is to evaluate the impact of circulating miR-126 on left ventricular remodeling and clinical outcomes in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.
Status | Completed |
Enrollment | 1200 |
Est. completion date | July 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation =2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes; - Age =18 years; - Informed consent from patient or next of kin. Exclusion Criteria: - Nonischaemic Cardiomyopathy; - Cardiac surgery planed in the 6 months; - Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation); - Renal or hepatic failure; - Malignancy, HIV, or central nervous system disorder; - Cardiopulmonary resuscitation >15 min and compromised level of consciousness; - Cardiogenic shock; - Current participation in any research study involving investigational drugs or devices; - No written consensus; - Previous myocardial infarction. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Beijing Friendship Hospital Affiliated to Capital Medical University | Beijing | |
China | Beijing Hospital | Beijing | |
China | Affiliated Hospital of Binzhou Medical Universty | Binzhou | Shandong |
China | Heze Municipal Hospital | Heze | Shandong |
China | Jinan Central Hospital, Shandong University | Jinan | Shandong |
China | Qianfoshan Hospital, Shandong University | Jinan | Shandong |
China | Qilu Hospital, Shandong University | Jinan | Shandong |
China | Shandong Provincial Hospital, Shandong University | Jinan | Shandong |
China | Shandong Provincial Medical Imaging Institute, Shandong University | Jinan | Shandong |
China | The Second Hospital of Shandong University | Jinan | Shandong |
China | Jining Hospital of Traditional Chinese Medicine | Jining | Shandong |
China | Qihe People's Hospital | Qihe | Shandong |
China | Affiliated Hospital of Qingdao University Medical College | Qingdao | Shandong |
China | Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai |
China | Weihai Municipal Hospital | Weihai | Shandong |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
China | Central Hospital of Zibo | Zibo | Shandong |
Lead Sponsor | Collaborator |
---|---|
Qilu Hospital | Beijing Friendship Hospital, Beijing Hospital, Binzhou Medical University, Central Hospital of Zibo, Heze Municipal Hospital, Jinan Central Hospital Affiliated to Shandong University, Jining Hospital of Traditional Chinese Medicine, Qianfoshan Hospital, Qihe People's Hospital, Qingdao University, Ruijin Hospital, Shandong Provincial Hospital Affiliated to Shandong University, Shandong Provincial Medical Imaging Institute of Shandong University, The First Affiliated Hospital of Zhengzhou University, The Second Hospital of Shandong University, Weihai Municipal Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in LVEDV from baseline by 3D-echocardiogram | The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) at 6 months post-PCI by 3D-echocardiogram. | 6 months | No |
Secondary | Major adverse cardiovascular events (MACE) | Cardiovascular death, myocardial infarction, target vessel revascularization,recurrent ischaemia, heart failure | 6 months | No |
Secondary | All cause mortality | 6 months | No | |
Secondary | Stent thrombosis | 6 months | No | |
Secondary | Change in LVESV from baseline | Change from baseline in left ventricular end systolic volume (LVESV), ejection fraction (LVEF) and mass at 6 months post-PCI by 3D-echocardiogram | 6 months | No |
Secondary | NT-proBNP levels | at 1 and 180 days post-PCI | No | |
Secondary | Incidence of complete ST-segment resolution | 3 hours after PCI | No | |
Secondary | Peak troponin T level | 24 hours after PCI | No |
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