Ignite Creation Date:
2024-05-06 @ 3:18 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02255344
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2014-09-25
Brief Title:
Multicenter Study to Develop a Risk Model for Early Major Cardiovascular Events
Sponsor:
Instituto Mexicano del Seguro Social
Organization:
Instituto Mexicano del Seguro Social
Study Overview
Official Title:
Multicenter Study to Develop a Risk Model for Early Major Cardiovascular Events Based on the IMSS National Registry of Acute Coronary Syndromes RENASCA IMSS Stage 1
Status:
COMPLETED
Status Verified Date:
2020-02
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:
RENASCA-IMSS
Brief Summary:
Through the National Registry of patients with ACS in the IMSS RENASCA IMSS the investigators will know the real world in terms of risk factors frequency clinical presentation and its complications and in the end they can build a risk model for early Major Cardiovascular Events MACE
Detailed Description:
Introduction Ischemic heart diseases as the leading cause of death in Mexico are mainly due to acute myocardial infarction In this sense reperfusion strategies are the cornerstone of treatment to reduce complications and costs however less than 50 percent of patients receive this treatment as a third of the worlds population dies by this cause
The World Health Organization WHO predicts for the next two decades about 235 million deaths worldwide by cardiovascular diseases Particularly Acute Coronary Syndrome ACS caused in 2008 about seven million deaths worldwide It is estimated that each year in Mexico around 300 thousand people suffer an ACS at least 60 percent of these is caused by Myocardial Infarction MI but there are not real numbers for morbidity nor real clinical complications
Efforts have been made in Mexican registries of ACS as shown in the first real world study done in the IMSS which serves the greater number of these cases 544 percent called National Registry of Acute Coronary Syndromes RENASCA IMSS In this registry 10 tertiary care hospitals participated enrolling 2398 patients with ACS diagnosis most of them with ST-Elevation Myocardial Infarction STEMI representing 63 percent the average age was 62 years In 65 percent of cases stratified as high risk GRACE 150 points only 42 percent were treated with fibrinolytic therapy 8 percent with primary Percutaneous Coronary Intervention PCI and the remaining 50 percent did not receive any reperfusion therapy which is the cornerstone for the prognosis of these patients
Currently Mexico is experiencing an increase in the elderly population and in the frequency of traditional risk factors for atherosclerosis associated with factors such as overweight and obesity which has become a high-risk population group for ischemic heart diseases and its complications It represents a challenge to the health system from the point of view of prevention in the beginning but also in the diagnosis prognosis and treatment
Treatment goals in traditional risk factors have not been accomplished yet Patients are diagnosed late and there is not a risk model in our population since more than 50 percent of patients do not receive adequate treatment
Therefore it is necessary to have a current outlook of what is happening in the mexican population through a National Registry of patients with ACS in the IMSS RENASCA IMSS This will allow to know the real world in terms of risk factors frequency clinical presentation and its complications and in the end a risk model can be built
OBJECTIVE To develop a risk model for early Major Cardiovascular Events MACE in patients with Acute Coronary Syndrome ACS based on the IMSS National Registry of Acute Coronary Syndromes RENASCA IMSS
MATERIAL AND METHODS Consecutive patients of any gender between 18 and 90 years old diagnosed with Acute Coronary Syndrome STEMI NSTEMI Unstable angina - according to international diagnostic criteria - American College of Cardiology ACC American Heart Association AHA European society of Cardiology ESC attended in representative hospitals of tertiary care in the IMSS will be studied
The design is an analytical consecutive prospective multicenter study with an emerging cohort of patients with ACS through a National Registry in units of tertiary care in the IMSS RENASCA IMSS Follow-up will be done during hospitalization and 30 days time of most Major Cardiovascular Events presentation MACE derived from the timing of initial treatment or lack of it
MACE to evaluate during Follow-up will be Reinfarction myocardial ischemia heart failure electrocardiographic complications and or death mortality 8 tertiary care hospitals or Medical Units of High Specialty UMAES for its acronym in Spanish will participated representing the country an analysis of clinical and paraclinical variables contained in the record considered as relevant in predicting the inception cohort for MACE during hospitalization and 30 days will be done The cohort of major cardiovascular events as previously defined will be compared with the cohort comprised by patients without such events
Statistical analysis will be done with central tendency and dispersion measures according to the distribution of the variables We will use the hypothesis testing according to the normality of data with T-test for independent groups or Mann-Whitney test for continuous variables whereas for categorical variables X2 test or Fisher exact test when the observed frequency is 5 will be used The free event will be analyzed with Kaplan Meier curves To determine the correlation of performers blind and independent of angiography and echocardiography we will use the Kappa index
The development of the risk model will be performed with logistic regression which dependent variable is the presence of MACE during hospitalization and 30 days Wald method backward Variables for clinical and epidemiological history considered as relevant will be included according also with the biological and epidemiological consistency and plausibility The statistical criteria will be the inclusion of variables that in the bivariate analysis show p 020 and the exit criteria of the model will be p005
The discriminative power of the model will be done with the area under the Receiver Operating Characteristic curve ROC curve The calibration will be done with the Hosmer-Lemeshow test Relative risk with confidence intervals of 95 percent will be calculated All hypothesis tests will be done under an alpha level of 005
TIME OF DEVELOPMENT Two years
The World Health Organization WHO predicts for the next two decades about 235 million deaths worldwide by cardiovascular diseases Particularly Acute Coronary Syndrome ACS caused in 2008 about seven million deaths worldwide It is estimated that each year in Mexico around 300 thousand people suffer an ACS at least 60 percent of these is caused by Myocardial Infarction MI but there are not real numbers for morbidity nor real clinical complications
Efforts have been made in Mexican registries of ACS as shown in the first real world study done in the IMSS which serves the greater number of these cases 544 percent called National Registry of Acute Coronary Syndromes RENASCA IMSS In this registry 10 tertiary care hospitals participated enrolling 2398 patients with ACS diagnosis most of them with ST-Elevation Myocardial Infarction STEMI representing 63 percent the average age was 62 years In 65 percent of cases stratified as high risk GRACE 150 points only 42 percent were treated with fibrinolytic therapy 8 percent with primary Percutaneous Coronary Intervention PCI and the remaining 50 percent did not receive any reperfusion therapy which is the cornerstone for the prognosis of these patients
Currently Mexico is experiencing an increase in the elderly population and in the frequency of traditional risk factors for atherosclerosis associated with factors such as overweight and obesity which has become a high-risk population group for ischemic heart diseases and its complications It represents a challenge to the health system from the point of view of prevention in the beginning but also in the diagnosis prognosis and treatment
Treatment goals in traditional risk factors have not been accomplished yet Patients are diagnosed late and there is not a risk model in our population since more than 50 percent of patients do not receive adequate treatment
Therefore it is necessary to have a current outlook of what is happening in the mexican population through a National Registry of patients with ACS in the IMSS RENASCA IMSS This will allow to know the real world in terms of risk factors frequency clinical presentation and its complications and in the end a risk model can be built
OBJECTIVE To develop a risk model for early Major Cardiovascular Events MACE in patients with Acute Coronary Syndrome ACS based on the IMSS National Registry of Acute Coronary Syndromes RENASCA IMSS
MATERIAL AND METHODS Consecutive patients of any gender between 18 and 90 years old diagnosed with Acute Coronary Syndrome STEMI NSTEMI Unstable angina - according to international diagnostic criteria - American College of Cardiology ACC American Heart Association AHA European society of Cardiology ESC attended in representative hospitals of tertiary care in the IMSS will be studied
The design is an analytical consecutive prospective multicenter study with an emerging cohort of patients with ACS through a National Registry in units of tertiary care in the IMSS RENASCA IMSS Follow-up will be done during hospitalization and 30 days time of most Major Cardiovascular Events presentation MACE derived from the timing of initial treatment or lack of it
MACE to evaluate during Follow-up will be Reinfarction myocardial ischemia heart failure electrocardiographic complications and or death mortality 8 tertiary care hospitals or Medical Units of High Specialty UMAES for its acronym in Spanish will participated representing the country an analysis of clinical and paraclinical variables contained in the record considered as relevant in predicting the inception cohort for MACE during hospitalization and 30 days will be done The cohort of major cardiovascular events as previously defined will be compared with the cohort comprised by patients without such events
Statistical analysis will be done with central tendency and dispersion measures according to the distribution of the variables We will use the hypothesis testing according to the normality of data with T-test for independent groups or Mann-Whitney test for continuous variables whereas for categorical variables X2 test or Fisher exact test when the observed frequency is 5 will be used The free event will be analyzed with Kaplan Meier curves To determine the correlation of performers blind and independent of angiography and echocardiography we will use the Kappa index
The development of the risk model will be performed with logistic regression which dependent variable is the presence of MACE during hospitalization and 30 days Wald method backward Variables for clinical and epidemiological history considered as relevant will be included according also with the biological and epidemiological consistency and plausibility The statistical criteria will be the inclusion of variables that in the bivariate analysis show p 020 and the exit criteria of the model will be p005
The discriminative power of the model will be done with the area under the Receiver Operating Characteristic curve ROC curve The calibration will be done with the Hosmer-Lemeshow test Relative risk with confidence intervals of 95 percent will be calculated All hypothesis tests will be done under an alpha level of 005
TIME OF DEVELOPMENT Two years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None