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Completed

NCT Number: NCT01875484

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Left Ventricular Remodeling Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Remodeling miR-126

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in LVEDV from baseline by 3D-echocardiogram

    Time frame: 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 outcomes

  1. Major adverse cardiovascular events (MACE)

    Time frame: 6 months

    Cardiovascular death, myocardial infarction, target vessel revascularization,recurrent ischaemia, heart failure

  2. All cause mortality

    Time frame: 6 months

  3. Stent thrombosis

    Time frame: 6 months

  4. Change in LVESV from baseline

    Time frame: 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

  5. NT-proBNP levels

    Time frame: at 1 and 180 days post-PCI

  6. Incidence of complete ST-segment resolution

    Time frame: 3 hours after PCI

  7. Peak troponin T level

    Time frame: 24 hours after PCI

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

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

Registry information

Official study 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.

Acronym: PMIR-miR-126

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 11, 2013
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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