Myocardial InfarctionPMIR-miR-126NCT01875484
Circulating miR-126 as a Novel Biomarker for Post Myocardial Infarction Remodeling
An observational study of Myocardial Infarction and Left Ventricular Remodeling, run by Qilu Hospital of Shandong University at 17 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Left Ventricular Remodeling, miR-126
- How many people
- 1,200 participants
- Where
- 17 sitesChina
- Study dates
- Feb 2012to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing primary PCI for STEMI
Who may be able to join
- 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.
Who cannot join
- 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;
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- Cardiogenic shock;
- Current participation in any research study involving investigational drugs or devices;
- No written consensus;
- Previous myocardial infarction.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Beijing Friendship Hospital Affiliated to Capital Medical University
Beijing
Beijing Hospital
Beijing
Affiliated Hospital of Binzhou Medical Universty
Binzhou, Shandong
Heze Municipal Hospital
Heze, Shandong
Qianfoshan Hospital, Shandong University
Jinan, Shandong, 250012
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Jinan Central Hospital, Shandong University
Jinan, Shandong, 250013
Shandong Provincial Hospital, Shandong University
Jinan, Shandong, 250021
Shandong Provincial Medical Imaging Institute, Shandong University
Jinan, Shandong, 250021
The Second Hospital of Shandong University
Jinan, Shandong
Jining Hospital of Traditional Chinese Medicine
Jining, Shandong
Qihe People's Hospital
Qihe, Shandong
Affiliated Hospital of Qingdao University Medical College
Qingdao, Shandong, 266003
Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200025
Weihai Municipal Hospital
Weihai, Shandong
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Central Hospital of Zibo
Zibo, Shandong
About this study
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.
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.
- 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
- Medical subject headings
- Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High miR-126 group | Not described | |
| Moderate miR-126 group | Not described | |
| Low miR-126 group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
Major adverse cardiovascular events (MACE)
Cardiovascular death, myocardial infarction, target vessel revascularization,recurrent ischaemia, heart failure
Measured: 6 months
All cause mortality
Measured: 6 months
Stent thrombosis
Measured: 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
Measured: 6 months
NT-proBNP levels
Measured: at 1 and 180 days post-PCI
Incidence of complete ST-segment resolution
Measured: 3 hours after PCI
Peak troponin T level
Measured: 24 hours after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startFeb 2012
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital, Jinan Central Hospital, Shandong Provincial Hospital, The Second Hospital of Shandong University, Ruijin Hospital, Qingdao University, Shandong Provincial Medical Imaging Institute of Shandong University, The First Affiliated Hospital of Zhengzhou University, Heze Municipal Hospital, Jining Hospital of Traditional Chinese Medicine, Qihe People's Hospital, Central Hospital of Zibo, Weihai Municipal Hospital, Beijing Friendship Hospital, Binzhou Medical University, Beijing Hospital
- Responsible party
- Principal investigator, Pan-Pan Hao, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875484
- Sponsor's protocol ID
- 2012CB518603
- Acronym
- PMIR-miR-126
- Status last verified
- Jul 2015
- First submitted
- 7 May 2013
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01875484
- Acronym / sponsor ID
- PMIR-miR-126 / 2012CB518603
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital, Jinan Central Hospital, Shandong Provincial Hospital, The Second Hospital of Shandong University, Ruijin Hospital, Qingdao University, Shandong Provincial Medical Imaging Institute of Shandong University, The First Affiliated Hospital of Zhengzhou University, Heze Municipal Hospital, Jining Hospital of Traditional Chinese Medicine, Qihe People's Hospital, Central Hospital of Zibo, Weihai Municipal Hospital, Beijing Friendship Hospital, Binzhou Medical University, Beijing Hospital
- Study start
- Feb 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High miR-126 group | – | – |
| Moderate miR-126 group | – | – |
| Low miR-126 group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing primary PCI for STEMI
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Major adverse cardiovascular events (MACE)
Time frame: 6 months
All cause mortality
Time frame: 6 months
Stent thrombosis
Time frame: 6 months
Change in LVESV from baseline
Time frame: 6 months
NT-proBNP levels
Time frame: at 1 and 180 days post-PCI
Incidence of complete ST-segment resolution
Time frame: 3 hours after PCI
Peak troponin T level
Time frame: 24 hours after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Left Ventricular Remodeling, run by Qilu Hospital of Shandong University at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LVEDV from baseline by 3D-echocardiogram (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.