Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02283619
Status:
TERMINATED
Last Update Posted:
2015-09-28
First Post:
2014-10-31
Brief Title:
Left Bundle Branch Block ECG Characteristics in the Evaluation of Acute Coronary Syndrome
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Correlation of Clinical Outcomes With ECG Findings in Patients With Left Bundle Branch Block Being Evaluated for Acute Coronary Syndrome - a Prospective Cohort Study
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was found to be non-feasible Not enough patients to perform an adequate study in the allocated time period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose of the study
The goal of this study is to evaluate the relationship of electrocardiogram ECG findings with clinical outcomes in a cohort of patients with left bundle branch block LBBB who are being evaluated for acute coronary syndrome ACS in the Emergency Department ED
Background and significance
The significance of specific ECG findings in patients with LBBB being evaluated for ACS has been inadequately studied and this gap in knowledge is a barrier to optimal management of this population Due to the speed availability low cost and non-invasive nature of the ECG it would be ideal to identify ECG characteristics that help to risk stratify these patients in order to inform clinical decision-making reduce unnecessary invasive testing and conserve resources
Methods
In this prospective observational study the investigators will identify a consecutive series of adult patients with LBBB presenting to the ED with suspicion of ACS The investigators will collect data including demographics cardiac risk factors initial ECG measurements lab and radiographic results procedure results and clinical outcomes such as 30-day death or myocardial infarction MI The investigators will analyze the data using a cohort study design to calculate odds ratios between ECG characteristics and the outcomes of interest
The goal of this study is to evaluate the relationship of electrocardiogram ECG findings with clinical outcomes in a cohort of patients with left bundle branch block LBBB who are being evaluated for acute coronary syndrome ACS in the Emergency Department ED
Background and significance
The significance of specific ECG findings in patients with LBBB being evaluated for ACS has been inadequately studied and this gap in knowledge is a barrier to optimal management of this population Due to the speed availability low cost and non-invasive nature of the ECG it would be ideal to identify ECG characteristics that help to risk stratify these patients in order to inform clinical decision-making reduce unnecessary invasive testing and conserve resources
Methods
In this prospective observational study the investigators will identify a consecutive series of adult patients with LBBB presenting to the ED with suspicion of ACS The investigators will collect data including demographics cardiac risk factors initial ECG measurements lab and radiographic results procedure results and clinical outcomes such as 30-day death or myocardial infarction MI The investigators will analyze the data using a cohort study design to calculate odds ratios between ECG characteristics and the outcomes of interest
Detailed Description:
Purpose of the study
The goal of this study is to identify initial electrocardiogram ECG findings including STS ratio and T-wave morphology that predict clinical outcomes myocardial infarction positive stress test revascularization and death in a cohort of Emergency Department ED patients with left bundle branch block LBBB who are being evaluated for acute coronary syndrome ACS
Design procedures
The investigators will prospectively identify all adult 18yrs and older patients presenting to their institutions ED who are being evaluated for ACS and have LBBB on ECG The investigators will collect data on demographics including age but not date of birth cardiac risk factors date and time of presentation to the ED ECG measurements lab and radiographic results cardiac biomarker data including date and time of the sample stress test results coronary imaging results coronary catheterization results and clinical outcomes such as 30-day death or MI They will collect copies of ECGs and measure the following STS ratio ratio of the amplitude of ST segment deviation to the S wave amplitude T-wave morphology entirely discordant entirely concordant or biphasic to the PR interval and standard ST segment deviation A logistic regression analysis will be used to identify which ECG features are associated with 30-day death MI and revascularization In the sub-cohort of subjects with negative modified Sgarbossa criteria a subanalysis will identify the outcome rates for the following specific sub-populations those less than 2 consecutive partially-concordant T-wave leads and those with 2 or more consecutive partially-concordant T-wave leads
Selection of Subjects
The population will be patients age 18 or older who present to the ED with LBBB and suspected ACS The investigators expect the mean age of the study population to be approximately 60 years old with most patients between 40 and 90 They anticipate that these patients will on average have multiple medical comorbidities given that those with LBBB and ACS are reported to be a sicker older population with more cardiac risk factors than the usual ACS patient without LBBB Patients under age 18 will be excluded because they extremely rarely have ACS andor LBBB The investigators anticipate 300 subjects
Inclusion criteria age 18 and older LBBB on ECG presenting to the ED and being evaluated for ACS
Exclusion criteria prisoners institutionalized individuals patients who are incapable of giving legally effective consent patients who cannot understand spoken English
Consent process
After the initial screening process if the potential subject meets the inclusionexclusion criteria and does not object to learning more about the study during initial discussion with their primary provider then one of the key personnel trained and authorized to consent will approach the potential subject to discuss the study by explaining the following the purpose of the study and the future benefits it may provide in subsequent patients the prospective and observational nature of the study the study procedures the risks of loss of confidentiality and the safeguards against that risk All information will be clearly printed in plain language on the consent form The potential subject will then be given the choice to enroll in the study
Only the potential subject will be allowed to provide consent The potential subject will have until discharge or transfer from the Emergency Department to decide whether or not to participate in the study The minimal risks and minimal subject involvement justify this practical and logical time requirement The consent process will occur in the potential subjects room in the Emergency Department
Data Analysis Statistical Considerations
The data will be analyzed with a cohort study design calculating odds ratios between ECG characteristics and outcomes The two primary ECG characteristics investigated will be 1 presence of at least 2 consecutive leads with at least a partially concordant T-wave biphasic or entirely concordant and 2 the STS ratio the ratio of the ST-segment deviation to the S or R wave amplitude whichever greater Secondary ECG features measured will include heart rate rhythm intervals bundle branch blocks PR and ST segment deviations and concordancediscordance PQRST amplitudes QRS durations QT intervals T wave inversions segment contours and concavityconvexity The primary outcomes of interest will be 1 positive cardiac troponin T biomarker levels on index visit and 2 positive stress test results on index visit Secondary outcomes will include the rates of 30-day myocardial infarction 30-day death and 30-day revascularization
The investigators will present summary statistics on subject demographics ECG findings labimagingprocedure results and outcomes They will determine association between dichotomous outcomes of cardiac biomarker cTNT levels stress test MI death revascularization and normally distributed continuous clinical and demographic characteristics using t-tests for normally distributed continuous data or Wilcoxon tests for non-normally distributed data and with categorical characteristics using Fishers exact or Chi-squared tests Associations between continuous variables will be assessed using Spearman or Pearson correlations Significance of the tests will be assessed at alpha 005 Analysis will be conducted using SAS 93 SAS Institute Inc Cary NC
The goal of this study is to identify initial electrocardiogram ECG findings including STS ratio and T-wave morphology that predict clinical outcomes myocardial infarction positive stress test revascularization and death in a cohort of Emergency Department ED patients with left bundle branch block LBBB who are being evaluated for acute coronary syndrome ACS
Design procedures
The investigators will prospectively identify all adult 18yrs and older patients presenting to their institutions ED who are being evaluated for ACS and have LBBB on ECG The investigators will collect data on demographics including age but not date of birth cardiac risk factors date and time of presentation to the ED ECG measurements lab and radiographic results cardiac biomarker data including date and time of the sample stress test results coronary imaging results coronary catheterization results and clinical outcomes such as 30-day death or MI They will collect copies of ECGs and measure the following STS ratio ratio of the amplitude of ST segment deviation to the S wave amplitude T-wave morphology entirely discordant entirely concordant or biphasic to the PR interval and standard ST segment deviation A logistic regression analysis will be used to identify which ECG features are associated with 30-day death MI and revascularization In the sub-cohort of subjects with negative modified Sgarbossa criteria a subanalysis will identify the outcome rates for the following specific sub-populations those less than 2 consecutive partially-concordant T-wave leads and those with 2 or more consecutive partially-concordant T-wave leads
Selection of Subjects
The population will be patients age 18 or older who present to the ED with LBBB and suspected ACS The investigators expect the mean age of the study population to be approximately 60 years old with most patients between 40 and 90 They anticipate that these patients will on average have multiple medical comorbidities given that those with LBBB and ACS are reported to be a sicker older population with more cardiac risk factors than the usual ACS patient without LBBB Patients under age 18 will be excluded because they extremely rarely have ACS andor LBBB The investigators anticipate 300 subjects
Inclusion criteria age 18 and older LBBB on ECG presenting to the ED and being evaluated for ACS
Exclusion criteria prisoners institutionalized individuals patients who are incapable of giving legally effective consent patients who cannot understand spoken English
Consent process
After the initial screening process if the potential subject meets the inclusionexclusion criteria and does not object to learning more about the study during initial discussion with their primary provider then one of the key personnel trained and authorized to consent will approach the potential subject to discuss the study by explaining the following the purpose of the study and the future benefits it may provide in subsequent patients the prospective and observational nature of the study the study procedures the risks of loss of confidentiality and the safeguards against that risk All information will be clearly printed in plain language on the consent form The potential subject will then be given the choice to enroll in the study
Only the potential subject will be allowed to provide consent The potential subject will have until discharge or transfer from the Emergency Department to decide whether or not to participate in the study The minimal risks and minimal subject involvement justify this practical and logical time requirement The consent process will occur in the potential subjects room in the Emergency Department
Data Analysis Statistical Considerations
The data will be analyzed with a cohort study design calculating odds ratios between ECG characteristics and outcomes The two primary ECG characteristics investigated will be 1 presence of at least 2 consecutive leads with at least a partially concordant T-wave biphasic or entirely concordant and 2 the STS ratio the ratio of the ST-segment deviation to the S or R wave amplitude whichever greater Secondary ECG features measured will include heart rate rhythm intervals bundle branch blocks PR and ST segment deviations and concordancediscordance PQRST amplitudes QRS durations QT intervals T wave inversions segment contours and concavityconvexity The primary outcomes of interest will be 1 positive cardiac troponin T biomarker levels on index visit and 2 positive stress test results on index visit Secondary outcomes will include the rates of 30-day myocardial infarction 30-day death and 30-day revascularization
The investigators will present summary statistics on subject demographics ECG findings labimagingprocedure results and outcomes They will determine association between dichotomous outcomes of cardiac biomarker cTNT levels stress test MI death revascularization and normally distributed continuous clinical and demographic characteristics using t-tests for normally distributed continuous data or Wilcoxon tests for non-normally distributed data and with categorical characteristics using Fishers exact or Chi-squared tests Associations between continuous variables will be assessed using Spearman or Pearson correlations Significance of the tests will be assessed at alpha 005 Analysis will be conducted using SAS 93 SAS Institute Inc Cary NC
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