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

Myocardial Infarction Clinical Trial

— PMIR-miR-126  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875484
• Other study ID #: 2012CB518603
• 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

Related Conditions & MeSH terms

• Infarction
• Left Ventricular Remodeling
• miR-126
• Myocardial Infarction
• Ventricular Remodeling

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