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Prognostic Value of Copeptin for Infarct Size and Prognosis in Patients With ST-elevation Myocardial Infarction (GOODI)

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ClinicalTrials.gov Identifier: NCT03074214
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
YU Tong-tong, Shengjing Hospital

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.

Condition or disease Intervention/treatment
ST-elevation Myocardial Infarction Procedure: percutaneous coronary intervention

Detailed Description:

Acute myocardial infarction (AMI) is a major concern in public health in China. Ischemia/reperfusion injury cripples the treatment effect of reperfusion management, and increases the final myocardial infarct size. Copeptin is related to the prognosis of heart failure and AMI, and may be a potential prognostic biomarker for myocardial infarct size, myocardial function and outcomes in patients with STEMI undergoing PCI.This study will enroll consecutive STEMI patients undergoing PCI, who meet the inclusion and exclusion criteria, in a large-scale hospital in Northeast China. After obtaining an informed consent, blood samples will be drawn at the time of before, immediately after, and 3 days after PPCI. They will be collected in EDTA tubes and centrifuged for 10 min at 2000 g within 0.5 h. Plasma will be stored at −80°C until analysis. Plasma copeptin concentrations will be determined by a commercially available automated immunofluorescent assay (R&D Systems Inc. Minneapolis, USA). And other information about symptoms, functioning, quality of life, medical care, demographic characteristics, medical history, clinical features, diagnostic tests, medications and procedural data will be also collected. Baseline CMR will be performed 3-5 days after PPCI. All scans were performed on a 3.0 Tesla scanner. At 1 month, 3 month, and 12 month after discharge, participants will receive a follow-up by phone. At 6 month after discharge, participants will return to the clinic for follow up visits, and a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. Follow-up CMR scan will be conducted. Follow-up blood samples will be drawn for testing copeptin.

Sample Size Calculation A study size analysis was performed using PASS (version 11.0.4, 2011, NCSS, LLC, USA). In a previous study, the 90-day primary composite end point of all-causes death, ventricular fibrillation, cardiogenic shock, and congestive heart failure requiring rehospitalization or an emergency room visit through 90 days was 10.3% in STEMI patients undergoing PCI. [1] Although available data for detecting clinically relevance between copeptin and prognosis in STEMI patients undergoing PCI was limited, a previous study demonstrated that a high concentration (quartile 4 vs. quartiles 1 to 3) of copeptin identified an increased risk of CV death or HF (HR:2.80,95%CI:2.24-3.51,P<0.001). [2] When the ratio between groups1 and 2 is 3:1, an overall sample size of 275 subjects, of which 207 are in group 1 and 68 are in group 2, achieves 90% power at a 0.0500 significance level to detect a difference of 0.1280 between 0.9290 and 0.8010--the proportions surviving in groups 1 and 2, respectively. The proportion of patients lost during follow up was 0.1000.


Study Type : Observational
Estimated Enrollment : 275 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
STEMI patients receiving PCI
patients with STEMI receiving percutaneous coronary intervention
Procedure: percutaneous coronary intervention
All STEMI patients enrolled will at first receive "Device"(such as: stent or balloon) treatment for their coronary artery.




Primary Outcome Measures :
  1. Major adverse cardiovascular events (MACE) [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 6 months ]
    All-cause death

  2. Cardiac death [ Time Frame: 6 months ]
    Cardiac death

  3. unplanned repeat revascularization [ Time Frame: 6 months ]
    unplanned repeat revascularization which included any unplanned repeat PCI or surgical bypass of target or non-target vessels

  4. congestive heart failure requiring rehospitalization or an emergency room visit [ Time Frame: 6 months ]
    congestive heart failure requiring rehospitalization or an emergency room visit

  5. angina requiring rehospitalization or an emergency room visit [ Time Frame: 6 months ]
    angina requiring rehospitalization or an emergency room visit

  6. ventricular fibrillation or severe ventricular tachycardia [ Time Frame: 6 months ]
    ventricular fibrillation or severe ventricular tachycardia with hemodynamic instability occurring more than 2 hours after PCI

  7. acute heart failure during the index hospitalization [ Time Frame: 6 months ]
    acute heart failure during the index hospitalization

  8. in-stent stent thrombosis [ Time Frame: 6 months ]
    acute, subacute or chronic in-stent stent thrombosis

  9. contrast-induced nephropathy [ Time Frame: 6 months ]
    Contrast-induced nephropathy was defined as an increase in serum creatinine concentration ≥0.5 mg/dl (44.2 mmol/l) or ≥25% above baseline 72 h after exposure to the contrast medium.

  10. ischemia stroke [ Time Frame: 6 months ]
    ischemia stroke was defined as an acute event of non-hemorrhagic cerebrovascular origin causing focal or global neurologic dysfunction lasting >24 h, which was confirmed by both clinical and radiographic criteria.

  11. Bleeding Academic Research Consortium Definition for Bleeding: type 3 or 5 [ Time Frame: 6 months ]
    Bleeding Academic Research Consortium Definition for Bleeding: Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to 5 g/dL* (provided hemoglobin drop is related to bleed) Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop 5 g/dL* (provided hemoglobin drop is related to bleed) Cardiac tamponade Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) Bleeding requiring intravenous vasoactive agents;Type 3c Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 5: fatal bleeding Type 5a Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation

  12. Seattle angina questionnaire (SAQ) [ Time Frame: 6 months ]
    Seattle angina questionnaire (SAQ)

  13. Quality of life (EQ-5D) [ Time Frame: 6 months ]
    Quality of life (EQ-5D)

  14. Depression (PHQ-8) [ Time Frame: 6 months ]
    Depression (PHQ-8)

  15. Stress (Chinese 14-item PSS) [ Time Frame: 6 months ]
    Stress (Chinese 14-item PSS)

  16. Cognitive function (MMSE) [ Time Frame: 6 months ]
    Cognitive function (MMSE)

  17. myocardial infarct size [ Time Frame: 6 months ]
    myocardial infarct size


Biospecimen Retention:   Samples Without DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
275 patients with STEMI receiving PPCI in department of Cardiology, Shengjing Hospital of China Medical University from March 1, 2017 to February 28, 2019
Criteria

Inclusion Criteria:

  1. chest pain present less than 12 hours from onset of pain to time of catheterization;
  2. 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;
  3. receiving primary PCI.

Exclusion Criteria:

  1. 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;
  2. Patients with contraindications to perform cardiac magnetic resonance;
  3. Patients with cardiogenic shock (Killip class IV);
  4. Patients in whom reperfusion therapy failed;
  5. Patients who were referred for emergency coronary artery bypass grafting (CABG) in view of unfavourable coronary anatomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074214


Contacts
Contact: Tongtong Yu, Doctor 8602496615 ext 22211 workhard31@vip.163.com
Contact: Zhijun Su, Doctor 8602496615 ext 22212 sunzj@sj-hospital.org

Locations
China, Liaoning
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 8611004
Contact: Hong Wang, Doctor    8602496615 ext 10026    llwyh@sj-hospital.org   
Contact: Qiyong Guo, Doctor    8602496615 ext 10027    guoqy@sj-hospital.org   
Sponsors and Collaborators
Shengjing Hospital
Investigators
Study Chair: Zhaoqing Su, Doctor Shengjing Hospital

Publications:
Responsible Party: YU Tong-tong, Principal Investigator, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03074214     History of Changes
Other Study ID Numbers: 2016PS373K
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not share IPD to protect our data very well.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by YU Tong-tong, Shengjing Hospital:
copeptin
myocardial infarct size
prognosis
ST-elevation myocardial infarction
percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Diabetes Insipidus
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs