Circulating miR-126 as a Novel Biomarker for Post Myocardial Infarction Remodeling

Completed

• Conditions: Left Ventricular Remodeling; Myocardial Infarction; miR-126

• Registration Number: NCT01875484
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Primary Completion: 2015-06
• Status Verified: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Stent thrombosis	6 months
Peak troponin T level	24 hours after PCI
Major adverse cardiovascular events (MACE)	6 months	Cardiovascular death, myocardial infarction, target vessel revascularization,recurrent ischaemia, heart failure
All cause mortality	6 months
NT-proBNP levels	at 1 and 180 days post-PCI
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
Incidence of complete ST-segment resolution	3 hours after PCI

Trial Locations

Locations (17)

The Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Affiliated Hospital of Binzhou Medical Universty; 🇨🇳 Binzhou, Shandong, China

Weihai Municipal Hospital; 🇨🇳 Weihai, Shandong, China

Qihe People's Hospital; 🇨🇳 Qihe, Shandong, China

Heze Municipal Hospital; 🇨🇳 Heze, Shandong, China

Qianfoshan Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China

Jinan Central Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China

Shandong Provincial Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China

Shandong Provincial Medical Imaging Institute, Shandong University; 🇨🇳 Jinan, Shandong, China

Jining Hospital of Traditional Chinese Medicine; 🇨🇳 Jining, Shandong, China

Beijing Friendship Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, China

Beijing Hospital; 🇨🇳 Beijing, China

Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China

Affiliated Hospital of Qingdao University Medical College; 🇨🇳 Qingdao, Shandong, China

Central Hospital of Zibo; 🇨🇳 Zibo, Shandong, China