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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01875484
Other study ID # 2012CB518603
Secondary ID
Status Completed
Phase N/A
First received May 7, 2013
Last updated July 28, 2015
Start date February 2012
Est. completion date July 2015

Study information

Verified date July 2015
Source Qilu Hospital
Contact n/a
Is FDA regulated No
Health authority China: National Natural Science Foundation
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

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

Sponsors (17)

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

Country where clinical trial is conducted

China, 

Outcome

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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