Prognostic Value of Copeptin for Infarct Size and Prognosis in Patients With ST-elevation Myocardial Infarction
GOODI
Study of Prognostic Value of Copeptin for Myocardial Infarct Size and 6-month Prognosis in Patients With ST-elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention: GOOD I Study
1 other identifier
observational
275
1 country
1
Brief Summary
ST-elevation myocardial infarction (STEMI) has a serious health threaten to population. PCI, which can timely restore the blood flow to the ischemic myocardium, is a well-proved measure in STEMI management. However, the process of the restoration can induce injury. The phenomenon is defined as ischemia/reperfusion (I/R) injury. The studies indicate that I/R injury accounts for up to 50% of the final myocardial infarct size. However, previous attempts to target known mediators of myocardial I/R injury in patients have been disappointing, leading to calls for a reevaluation of factors affecting myocardial I/R injury \[1\]. Arginine vasopressin (AVP), that response to acute illness, is unstable and cleared rapidly from the circulation. However, copeptin, the C-terminal portion of provasopressin, is released in equimolar amounts to AVP and is easy to determine. So, copeptin can be a surrogate marker for AVP secretion. Recently, copeptin was found to serve as a potential prognostic biomarker in heart failure and acute myocardial infarction (AMI). AMI can activate the AVP axis, which have a causative role in the evolution of heart failure. Increasing copeptin was shown to correlate with myocardial remodeling, mortality and morbidity. In patients with STEMI, myocardial infarct size is a stronger outcome predictor than LV function, and is related to LV remodeling, which often indicates a significant worse prognosis after AMI. As the gold standard for characterisation of cardiac structure and function, cardiac magnetic resonance (CMR) parameters can serve as surrogate end points in clinical trials of STEMI. We hypothesised that plasma copeptin values, tested before and after PCI, are related to myocardial infarct size, myocardial function both and outcomes at baseline and 6 months follow-up as assessed by CMR in patients with STEMI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Typical duration for all trials
1 active site
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
First Submitted
Initial submission to the registry
February 28, 2017
CompletedStudy Start
First participant enrolled
March 6, 2017
CompletedFirst Posted
Study publicly available on registry
March 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedMarch 10, 2017
March 1, 2017
2 years
February 28, 2017
March 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major adverse cardiovascular events (MACE)
Composite of MACE including cardiac death, non-fatal myocardial reinfarction, unplanned repeat revascularization, congestive heart failure or angina requiring rehospitalization or an emergency room visit, ventricular fibrillation or ventricular tachycardia with hemodynamic instability
6 months
Secondary Outcomes (17)
All-cause death
6 months
Cardiac death
6 months
unplanned repeat revascularization
6 months
congestive heart failure requiring rehospitalization or an emergency room visit
6 months
angina requiring rehospitalization or an emergency room visit
6 months
- +12 more secondary outcomes
Study Arms (1)
STEMI patients receiving PCI
patients with STEMI receiving percutaneous coronary intervention
Interventions
All STEMI patients enrolled will at first receive "Device"(such as: stent or balloon) treatment for their coronary artery.
Eligibility Criteria
275 patients with STEMI receiving PPCI in department of Cardiology, Shengjing Hospital of China Medical University from March 1, 2017 to February 28, 2019
You may qualify if:
- chest pain present less than 12 hours from onset of pain to time of catheterization;
- significant ST-segment elevation (at least 0.1 mV in two or more standard leads or at least 0.2 mV in two or more contiguous precordial leads) or a new left bundle branch block;
- receiving primary PCI.
You may not qualify if:
- Patients with conditions other than STEMI that could cause increased copeptin levels, such as renal dysfunction (eGFR\<30 ml/min), liver failure, respiratory tract infection, stroke, sepsis, hyponatremia (Serum sodium concentration\<135mmol/L), central diabetes insipidus or malignancy;
- Patients with contraindications to perform cardiac magnetic resonance;
- Patients with cardiogenic shock (Killip class IV);
- Patients in whom reperfusion therapy failed;
- Patients who were referred for emergency coronary artery bypass grafting (CABG) in view of unfavourable coronary anatomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 8611004, China
Related Publications (2)
Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Janssens L, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Kosmider M, Katz O, Neunteufl T, Jorgova J, Dorobantu M, Grinfeld L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med. 2008 May 22;358(21):2205-17. doi: 10.1056/NEJMoa0706816.
PMID: 18499565BACKGROUNDO'Malley RG, Bonaca MP, Scirica BM, Murphy SA, Jarolim P, Sabatine MS, Braunwald E, Morrow DA. Prognostic performance of multiple biomarkers in patients with non-ST-segment elevation acute coronary syndrome: analysis from the MERLIN-TIMI 36 trial (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes-Thrombolysis In Myocardial Infarction 36). J Am Coll Cardiol. 2014 Apr 29;63(16):1644-53. doi: 10.1016/j.jacc.2013.12.034. Epub 2014 Feb 13.
PMID: 24530676BACKGROUND
Biospecimen
A venous blood sample will be collected at before, immediately after, and 3 days after PPCI and 6-month visit for biomarker analysis and storage for future studies.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhaoqing Su, Doctor
Shengjing Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 8, 2017
Study Start
March 6, 2017
Primary Completion
February 28, 2019
Study Completion
August 31, 2019
Last Updated
March 10, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share
We will not share IPD to protect our data very well.