Ignite Creation Date:
2024-05-06 @ 9:47 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03074214
Status:
UNKNOWN
Last Update Posted:
2017-03-10
First Post:
2017-02-28
Brief Title:
Prognostic Value of Copeptin for Infarct Size and Prognosis in Patients With ST-elevation Myocardial Infarction
Sponsor:
Shengjing Hospital
Organization:
Shengjing Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GOODI
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 ischemiareperfusion IR injury The studies indicate that IR injury accounts for up to 50 of the final myocardial infarct size However previous attempts to target known mediators of myocardial IR injury in patients have been disappointing leading to calls for a reevaluation of factors affecting myocardial IR 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
Detailed Description:
Acute myocardial infarction AMI is a major concern in public health in China Ischemiareperfusion 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 PCIThis 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 05 h Plasma will be stored at -80C until analysis Plasma copeptin concentrations will be determined by a commercially available automated immunofluorescent assay RD 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 30 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 1104 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 103 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 HR28095CI224-351P0001 2 When the ratio between groups1 and 2 is 31 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 00500 significance level to detect a difference of 01280 between 09290 and 08010--the proportions surviving in groups 1 and 2 respectively The proportion of patients lost during follow up was 01000
Sample Size Calculation A study size analysis was performed using PASS version 1104 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 103 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 HR28095CI224-351P0001 2 When the ratio between groups1 and 2 is 31 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 00500 significance level to detect a difference of 01280 between 09290 and 08010--the proportions surviving in groups 1 and 2 respectively The proportion of patients lost during follow up was 01000
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None