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

Impact of Circulating miR-126 on Left Ventricular Remodeling and Clinical Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention. The PMIR-miR-126 Study.

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Hospital
  • Beijing, China
    • Beijing Friendship Hospital Affiliated to Capital Medical University
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Shandong
    • Binzhou, Shandong, China
      • Affiliated Hospital of Binzhou Medical Universty
    • Heze, Shandong, China
      • Heze Municipal Hospital
    • Jinan, Shandong, China, 250012
      • Qilu Hospital, Shandong University
    • Jinan, Shandong, China
      • The Second Hospital of Shandong University
    • Jinan, Shandong, China, 250012
      • Qianfoshan Hospital, Shandong University
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital, Shandong University
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital, Shandong University
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Medical Imaging Institute, Shandong University
    • Jining, Shandong, China
      • Jining Hospital of Traditional Chinese Medicine
    • Qihe, Shandong, China
      • Qihe People's Hospital
    • Qingdao, Shandong, China, 266003
      • Affiliated Hospital of Qingdao University Medical College
    • Weihai, Shandong, China
      • Weihai Municipal Hospital
    • Zibo, Shandong, China
      • Central Hospital of Zibo
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin hospital, school of medicine, Shanghai jiao tong university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing primary PCI for STEMI

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
High miR-126 group
Moderate miR-126 group
Low miR-126 group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: Beijing Friendship Hospital; Qingdao University; Ruijin Hospital; Shandong Provincial Hospital; Beijing Hospital; The First Affiliated Hospital of Zhengzhou University; Qianfoshan Hospital; Jinan Central Hospital; The Second Hospital of Shandong University; Weihai Municipal Hospital; Binzhou Medical University; Heze Municipal Hospital; Central Hospital of Zibo; Shandong Provincial Medical Imaging Institute of Shandong University; Jining Hospital of Traditional Chinese Medicine; Qihe People's Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Myocardial Infarction; primary percutaneous coronary intervention; left ventricular ejection fraction; major adverse cardiovascular events; Left Ventricular Remodeling; left ventricular end diastolic volume; miR-126
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Myocardial Infarction; Infarction; Ventricular Remodeling
• Other Study ID Numbers: 2012CB518603