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
|Condition or disease||Intervention/treatment|
|ST-elevation Myocardial Infarction||Procedure: percutaneous coronary intervention|
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.  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).  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|
|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|
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.
- 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
- All-cause death [ Time Frame: 6 months ]All-cause death
- Cardiac death [ Time Frame: 6 months ]Cardiac death
- 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
- congestive heart failure requiring rehospitalization or an emergency room visit [ Time Frame: 6 months ]congestive heart failure requiring rehospitalization or an emergency room visit
- angina requiring rehospitalization or an emergency room visit [ Time Frame: 6 months ]angina requiring rehospitalization or an emergency room visit
- 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
- acute heart failure during the index hospitalization [ Time Frame: 6 months ]acute heart failure during the index hospitalization
- in-stent stent thrombosis [ Time Frame: 6 months ]acute, subacute or chronic in-stent stent thrombosis
- 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.
- 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.
- 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
- Seattle angina questionnaire (SAQ) [ Time Frame: 6 months ]Seattle angina questionnaire (SAQ)
- Quality of life (EQ-5D) [ Time Frame: 6 months ]Quality of life (EQ-5D)
- Depression (PHQ-8) [ Time Frame: 6 months ]Depression (PHQ-8)
- Stress (Chinese 14-item PSS) [ Time Frame: 6 months ]Stress (Chinese 14-item PSS)
- Cognitive function (MMSE) [ Time Frame: 6 months ]Cognitive function (MMSE)
- myocardial infarct size [ Time Frame: 6 months ]myocardial infarct size
Biospecimen Retention: Samples Without DNA
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
|Contact: Tongtong Yu, Doctor||8602496615 ext firstname.lastname@example.org|
|Contact: Zhijun Su, Doctor||8602496615 ext email@example.com|
|Shengjing Hospital of China Medical University||Recruiting|
|Shenyang, Liaoning, China, 8611004|
|Contact: Hong Wang, Doctor 8602496615 ext 10026 firstname.lastname@example.org|
|Contact: Qiyong Guo, Doctor 8602496615 ext 10027 email@example.com|
|Study Chair:||Zhaoqing Su, Doctor||Shengjing Hospital|