Left Ventricular Remodeling, miR-126, Myocardial Infarction
Conditions
Keywords
miR-126, Left Ventricular Remodeling, Myocardial Infarction, primary percutaneous coronary intervention, left ventricular end diastolic volume, left ventricular ejection fraction, major adverse cardiovascular events
Brief summary
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.
Interventions
None listed
Sponsors
Qianfoshan Hospital
Jinan Central Hospital
Shandong Provincial Hospital
The Second Hospital of Shandong University
Ruijin Hospital
Qingdao University
Shandong Provincial Medical Imaging Institute of Shandong University
The First Affiliated Hospital of Zhengzhou University
Heze Municipal Hospital
Jining Hospital of Traditional Chinese Medicine
Qihe People's Hospital
Central Hospital of Zibo
Weihai Municipal Hospital
Beijing Friendship Hospital
Binzhou Medical University
Beijing Hospital
Qilu Hospital of Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LVEDV from baseline by 3D-echocardiogram | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 6 months | — |
| Stent thrombosis | 6 months | — |
| Change in LVESV from baseline | 6 months | Change from baseline in left ventricular end systolic volume (LVESV), ejection fraction (LVEF) and mass at 6 months post-PCI by 3D-echocardiogram |
| Major adverse cardiovascular events (MACE) | 6 months | Cardiovascular death, myocardial infarction, target vessel revascularization,recurrent ischaemia, heart failure |
| Incidence of complete ST-segment resolution | 3 hours after PCI | — |
| Peak troponin T level | 24 hours after PCI | — |
| NT-proBNP levels | at 1 and 180 days post-PCI | — |
Countries
China
Outcome results
None listed