Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03116854
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2017-04-12
Brief Title:
Real-world Use and Prognosis of Beta Blocker in Patients With Acute Coronary Syndrome in the Central China
Sponsor:
Henan Institute of Cardiovascular Epidemiology
Organization:
Henan Institute of Cardiovascular Epidemiology
Study Overview
Official Title:
Real-world Use and Prognosis of Beta Blocker in Patients With Acute Coronary Syndrome in the Central Chinaa Prospective Multicenter Observational Research
Status:
COMPLETED
Status Verified Date:
2020-04
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:
UPB-ACS
Brief Summary:
Beta Blocker therapy is a mainstay of treatment following acute coronary syndromes ACS particularly acute myocardial infarction MI Studies have repeatedly demonstrated the benefit of Beta blocker therapy following either ST-segment elevation myocardial infarction STEMI or non-ST-segment elevation ACSand Beta blocker therapy has been a performance measure used to grade hospital performance by the Centers for Medicare and Medicaid Services and Joint Commission on Accreditation of Healthcare OrganizationsAlthough the benefit of Beta blocker therapy has been clearly demonstrated the doses that have been used in many of these studies are significantly higher than those typically used currently in clinical practiceThe benefit of Beta blockers has been ascribed to dose-related heart rate reductionalthough alternative mechanisms for their benefit have also been proposedIn addition the classical Beta blocker trials were performed decades ago before the modern therapeutic erawhich includes reperfusion therapy potent antithrombotics and statins This raises the question of whether titration of Beta blocker therapy to the high doses that had been previously studied provides substantial incremental benefit in current clinical practice over the more frequently prescribed and clinically tolerated doses of Beta blockersMoreover a recent study has reported that high-dose Beta blockers were not superior to low-dose Beta blockersaprovocative finding requiring validation And until now there has been no registry on patients with ACS about Between Beta-blocker Treatment in Henan the most populated about 100 million and predominantly rural 66province in central China
This multicenter prospective observational study is aimed to analyze the application status and long-term prognostic benefit of beta-blockers in patients with acute coronary syndrome
This multicenter prospective observational study is aimed to analyze the application status and long-term prognostic benefit of beta-blockers in patients with acute coronary syndrome
Detailed Description:
1 Henan institute of cardiology epidemiology is responsible for design data quality control and statistical analysis
2 Data were collected using a uniformed Case Report FormCRF by trained staff at each hospital
3 Sample size estimation Based on retrospective observational cohort of ACS patients 1-year mortality in beta-blocker recipients and non-beta-blocker recipients were 25 and 56 respectively To achieve a precision of 5 with an α of 005 the loss ratio of following-up is 15The investigators would need a sample of 3000
4 Statistical analysis plan the investigators will report summary statistics for patient characteristics comorbidities treatment strategies and outcomes the investigators will also undertake the following prespecified subgroup analyses age sex STE-ACS or NSTE-ACS history of diabetes history of hypertension smokingand analyze the association Between Beta-blocker Treatment and Long-term Mortality
5 Quality assurance plan 1Diagnosis of ACS is according to the third universal definition2Before registry a training program on study objectives data collection and ACS management is given to the primary investigator and related staff at each participating center3Henan institute of cardiology epidemiology will regularly monitored at least 10 of CRFs for accuracy against medical records If the CRFs are not completed with 98 accuracy all CRFs are considered unqualified and this staff will be retrained4Before entering into the computer data is queried for invalid and illogical values by research staff in Henan institute of cardiology epidemiology Participating centres who has the high error rate of data and no change in 6 months shall be deemed abandoned automatically participating centres who has the high quality of data will be issued a certificate to reward5Investigator meeting will be annually held to conclude the progress solve existing problems and strengthen program training
2 Data were collected using a uniformed Case Report FormCRF by trained staff at each hospital
3 Sample size estimation Based on retrospective observational cohort of ACS patients 1-year mortality in beta-blocker recipients and non-beta-blocker recipients were 25 and 56 respectively To achieve a precision of 5 with an α of 005 the loss ratio of following-up is 15The investigators would need a sample of 3000
4 Statistical analysis plan the investigators will report summary statistics for patient characteristics comorbidities treatment strategies and outcomes the investigators will also undertake the following prespecified subgroup analyses age sex STE-ACS or NSTE-ACS history of diabetes history of hypertension smokingand analyze the association Between Beta-blocker Treatment and Long-term Mortality
5 Quality assurance plan 1Diagnosis of ACS is according to the third universal definition2Before registry a training program on study objectives data collection and ACS management is given to the primary investigator and related staff at each participating center3Henan institute of cardiology epidemiology will regularly monitored at least 10 of CRFs for accuracy against medical records If the CRFs are not completed with 98 accuracy all CRFs are considered unqualified and this staff will be retrained4Before entering into the computer data is queried for invalid and illogical values by research staff in Henan institute of cardiology epidemiology Participating centres who has the high error rate of data and no change in 6 months shall be deemed abandoned automatically participating centres who has the high quality of data will be issued a certificate to reward5Investigator meeting will be annually held to conclude the progress solve existing problems and strengthen program training
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