Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04544384
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2020-09-02
Brief Title:
Acute Myocardial Infarction in Iceland is There a Gender Difference in Treatment and Survival
Sponsor:
Landspitali University Hospital
Organization:
Landspitali University Hospital
Study Overview
Official Title:
Acute Myocardial Infarction in Iceland is There a Gender Difference in Treatment and Survival
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
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:
None
Brief Summary:
All patients in Iceland with STEMI 2008-2018 and NSTEMI 2013-2018 that underwent coronary angiography and had obstructive coronary artery disease were included Information about patients and angiography results and treatment were obtained from the Swedish Coronary Angiography and Angioplasty Registry SCAAR Survival was estimated with Kaplan-Meier method Cox regression analysis were used to identify significant risk factors for long-term mortality Relative survival was defined as observed survival divided by expected survival of the population of Iceland
Detailed Description:
Methods This is a retrospective observational nationwide study of all patients aged 18 years and older who underwent coronary angiography for acute myocardial infarction AMI during the study period All procedures were performed at Landspitali University Hospital which is a tertiary referral center and the only institution performing coronary angiographies in Iceland The study period was from January 1 2008 to December 31 2018 for ST elevation myocardial infarction STEMI and from January 1 2013 to December 31 2018 for non-ST elevation myocardial infarction NSTEMI For multiple admissions the first was retained
Information about patient demographics cardiovascular risk factors comorbidities angiography results and treatment were obtained from the Swedish Coronary Angiography and Angioplasty Registry SCAAR a Swedish Web-based database also used in Iceland that prospectively record both patient- and procedure-related factors All data are registered by the treating physician and nurses at the time of the procedure
Clinical definitions Cases of acute myocardial were defined as STEMI and NSTEMI according to the current European Society of Cardiology guidelines and determined by the attending cardiologist 18 The NSTEMI diagnosis was introduced into the database 2013 and there was also a change in the Troponin analysis used at that time This is the reason why we chose to have a shorter study period for the NSTEMI patients We excluded patients that had not significant coronary artery stenoses Cardiovascular risk factors including hypertension diabetes mellitus smoking status statin use body mass index BMI and renal function were recorded Chronic kidney disease CKD was staged according to the Kidney Disease Outcome Quality Initiative KDOQI classification Estimated glomerular filtration rate eGFR was calculated from serum creatinine measurements using the Chronic Kidney Disease Epidemiology Collaboration CKD-EPI equation and CKD was defined as eGFR 60 mLmin173 m2 stage 3-5
Prior MI percutaneous coronary intervention PCI and coronary artery bypass grafting CABG were recorded as defined in the database Since these were AMI patients they were all done urgently but it was also recorded whether they were done acutely as primary PCIs The results of the coronary angiography were expressed as the number of vessels involved with significant stenoses or left main stem disease based on angiographic results If PCI was performed it was recorded whether patients received aspirin acetylsalicylic acid or adenosine diphosphate receptor ADP inhibitor before or during the procedure The choice of treatment medical therapy alone PCI or CABG was at the discretion of the attending interventional cardiologist andor the heart team
Observed and Expected Survival Data for all-cause mortality were extracted through linkage with Statistics Iceland Patients were followed up for their vital status after hospitalization with censoring at the end of follow-up on October 23 2019 Expected survival was derived from the general population of Iceland matched to observed survival for the study population by sex age and year of hospitalization
Statistical analysis All calculations were performed using R software version 333 R Foundation for Statistical Computing Vienna Austria All continuous variables were normally distributed and were compared with Students t-test and presented as mean standard deviation SD Categorical variables were compared using Chi-square test if the observed data was over five otherwise Fishers Exact test was performed Statistical significance was prespecified at 5 P 005 Kaplan-Meier curve was plotted to assess the estimated long-term survival and the two groups were compared using a log-rank test To identify independent prognostic factors for survival a Cox multivariate analysis was used represented as hazard ratios with 95 confidence intervals
Relative survival was defined as the observed survival among patients with AMI divided by expected survival in populace of Iceland matched by sex age and year
As individual patients were not identified obtaining individual consent for the study was not obtained
Information about patient demographics cardiovascular risk factors comorbidities angiography results and treatment were obtained from the Swedish Coronary Angiography and Angioplasty Registry SCAAR a Swedish Web-based database also used in Iceland that prospectively record both patient- and procedure-related factors All data are registered by the treating physician and nurses at the time of the procedure
Clinical definitions Cases of acute myocardial were defined as STEMI and NSTEMI according to the current European Society of Cardiology guidelines and determined by the attending cardiologist 18 The NSTEMI diagnosis was introduced into the database 2013 and there was also a change in the Troponin analysis used at that time This is the reason why we chose to have a shorter study period for the NSTEMI patients We excluded patients that had not significant coronary artery stenoses Cardiovascular risk factors including hypertension diabetes mellitus smoking status statin use body mass index BMI and renal function were recorded Chronic kidney disease CKD was staged according to the Kidney Disease Outcome Quality Initiative KDOQI classification Estimated glomerular filtration rate eGFR was calculated from serum creatinine measurements using the Chronic Kidney Disease Epidemiology Collaboration CKD-EPI equation and CKD was defined as eGFR 60 mLmin173 m2 stage 3-5
Prior MI percutaneous coronary intervention PCI and coronary artery bypass grafting CABG were recorded as defined in the database Since these were AMI patients they were all done urgently but it was also recorded whether they were done acutely as primary PCIs The results of the coronary angiography were expressed as the number of vessels involved with significant stenoses or left main stem disease based on angiographic results If PCI was performed it was recorded whether patients received aspirin acetylsalicylic acid or adenosine diphosphate receptor ADP inhibitor before or during the procedure The choice of treatment medical therapy alone PCI or CABG was at the discretion of the attending interventional cardiologist andor the heart team
Observed and Expected Survival Data for all-cause mortality were extracted through linkage with Statistics Iceland Patients were followed up for their vital status after hospitalization with censoring at the end of follow-up on October 23 2019 Expected survival was derived from the general population of Iceland matched to observed survival for the study population by sex age and year of hospitalization
Statistical analysis All calculations were performed using R software version 333 R Foundation for Statistical Computing Vienna Austria All continuous variables were normally distributed and were compared with Students t-test and presented as mean standard deviation SD Categorical variables were compared using Chi-square test if the observed data was over five otherwise Fishers Exact test was performed Statistical significance was prespecified at 5 P 005 Kaplan-Meier curve was plotted to assess the estimated long-term survival and the two groups were compared using a log-rank test To identify independent prognostic factors for survival a Cox multivariate analysis was used represented as hazard ratios with 95 confidence intervals
Relative survival was defined as the observed survival among patients with AMI divided by expected survival in populace of Iceland matched by sex age and year
As individual patients were not identified obtaining individual consent for the study was not obtained
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