Clinical trial NCT01875484: Circulating miR-126 as a Novel Biomarker for Post Myocardial Infarction Remodeling
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Left Ventricular Remodeling
miR-126
Keywords: miR-126
Left Ventricular Remodeling
Myocardial Infarction
primary percutaneous coronary intervention
left ventricular end diastolic volume
left ventricular ejection fraction
major adverse cardiovascular events
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Qianfoshan Hospital
name: Jinan Central Hospital
name: Shandong Provincial Hospital
name: The Second Hospital of Shandong University
name: Ruijin Hospital
name: Qingdao University
name: Shandong Provincial Medical Imaging Institute of Shandong University
name: The First Affiliated Hospital of Zhengzhou University
name: Heze Municipal Hospital
name: Jining Hospital of Traditional Chinese Medicine
name: Qihe People's Hospital
name: Central Hospital of Zibo
name: Weihai Municipal Hospital
name: Beijing Friendship Hospital
name: Binzhou Medical University
name: Beijing Hospital
First posted: 2013-06-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing primary PCI for STEMI

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in LVEDV from baseline by 3D-echocardiogram
timeFrame: 6 months
Secondary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 6 months
measure: All cause mortality
timeFrame: 6 months
measure: Stent thrombosis
timeFrame: 6 months
measure: Change in LVESV from baseline
timeFrame: 6 months
measure: NT-proBNP levels
timeFrame: at 1 and 180 days post-PCI
measure: Incidence of complete ST-segment resolution
timeFrame: 3 hours after PCI
measure: Peak troponin T level
timeFrame: 24 hours after PCI
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Binzhou
country: China
facility: Affiliated Hospital of Binzhou Medical Universty
state: Shandong
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Jinan
country: China
facility: Qianfoshan Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Medical Imaging Institute, Shandong University
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: Jining Hospital of Traditional Chinese Medicine
state: Shandong
city: Qihe
country: China
facility: Qihe People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University Medical College
state: Shandong
city: Weihai
country: China
facility: Weihai Municipal Hospital
state: Shandong
city: Zibo
country: China
facility: Central Hospital of Zibo
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliated to Capital Medical University
city: Beijing
country: China
facility: Beijing Hospital
Study officials:
References: