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.
1 other identifier
observational
1,200
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJuly 30, 2015
July 1, 2015
3.3 years
May 7, 2013
July 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Major adverse cardiovascular events (MACE)
6 months
All cause mortality
6 months
Stent thrombosis
6 months
Change in LVESV from baseline
6 months
NT-proBNP levels
at 1 and 180 days post-PCI
- +2 more secondary outcomes
Study Arms (3)
High miR-126 group
Moderate miR-126 group
Low miR-126 group
Eligibility Criteria
Consecutive patients undergoing primary PCI for STEMI
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qilu Hospital of Shandong Universitylead
- Qianfoshan Hospitalcollaborator
- Jinan Central Hospitalcollaborator
- Shandong Provincial Hospitalcollaborator
- The Second Hospital of Shandong Universitycollaborator
- Ruijin Hospitalcollaborator
- Qingdao Universitycollaborator
- Shandong Provincial Medical Imaging Institute of Shandong Universitycollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Heze Municipal Hospitalcollaborator
- Jining Hospital of Traditional Chinese Medicinecollaborator
- Qihe People's Hospitalcollaborator
- Central Hospital of Zibocollaborator
- Weihai Municipal Hospitalcollaborator
- Beijing Friendship Hospitalcollaborator
- Binzhou Medical Universitycollaborator
- Beijing Hospitalcollaborator
Study Sites (17)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Affiliated Hospital of Binzhou Medical Universty
Binzhou, Shandong, China
Heze Municipal Hospital
Heze, Shandong, China
Qianfoshan Hospital, Shandong University
Jinan, Shandong, 250012, China
Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Jinan Central Hospital, Shandong University
Jinan, Shandong, 250013, China
Shandong Provincial Hospital, Shandong University
Jinan, Shandong, 250021, China
Shandong Provincial Medical Imaging Institute, Shandong University
Jinan, Shandong, 250021, 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, 266003, China
Weihai Municipal Hospital
Weihai, Shandong, China
Central Hospital of Zibo
Zibo, Shandong, China
Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200025, China
Beijing Friendship Hospital Affiliated to Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Biospecimen
Blood Samples: serum, plasma, RNA, DNA, microRNAs, CD34+ cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 7, 2013
First Posted
June 11, 2013
Study Start
February 1, 2012
Primary Completion
June 1, 2015
Study Completion
July 1, 2015
Last Updated
July 30, 2015
Record last verified: 2015-07