Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03619733
Status:
UNKNOWN
Last Update Posted:
2018-08-08
First Post:
2018-07-01
Brief Title:
Modified HEART as Rule Out for Suspected ACS
Sponsor:
Liverpool University Hospitals NHS Foundation Trust
Organization:
Liverpool University Hospitals NHS Foundation Trust
Study Overview
Official Title:
Does Modified Heart Score Incorporating Undetectable and 99th Percentile High Sensitivity Troponin T Limits Improve Early Safe Discharge for Suspected Acute Coronary Syndromes
Status:
UNKNOWN
Status Verified Date:
2018-08
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:
None
Brief Summary:
Validation of modified HEART score as a rule-out criterion for MACE at 6 weeks a 2 centre prospective observational cohort with a direct comparison to TIMI GRACE and high sensitive troponin T at limits of detection
Detailed description
The HEART score as defined previously by Backus et al1 is a risk score specifically developed for acute chest pain suspected acute coronary syndrome The conventional scoring system for the troponin component of HEART is as follows Troponin 99th percentile 0 in the case of Hstn T Roche 14ngl 99th percentile up to X3 URL 99th percentile 1 HSTN T 14-42ngL x3 URN 2 HSTN T 42ngl
We have previously defined that the optimal rule-out strategy for suspected acute coronary syndromes may well be a modified HEART score in a single centre study This study is to prospectively validate the use of this score in a prospective unselected cohort of patients with possible acute coronary syndrome at 2 large secondary care centres
Detailed description
The HEART score as defined previously by Backus et al1 is a risk score specifically developed for acute chest pain suspected acute coronary syndrome The conventional scoring system for the troponin component of HEART is as follows Troponin 99th percentile 0 in the case of Hstn T Roche 14ngl 99th percentile up to X3 URL 99th percentile 1 HSTN T 14-42ngL x3 URN 2 HSTN T 42ngl
We have previously defined that the optimal rule-out strategy for suspected acute coronary syndromes may well be a modified HEART score in a single centre study This study is to prospectively validate the use of this score in a prospective unselected cohort of patients with possible acute coronary syndrome at 2 large secondary care centres
Detailed Description:
Validation of modified HEART score as a rule-out criterion for MACE at 6 weeks a 2 centre prospective observational cohort with a direct comparison to TIMI GRACE and high sensitive troponin T at limits of detection
Detailed description
The HEART score as defined previously by Backus et al1 is a risk score specifically developed for acute chest pain suspected acute coronary syndrome The conventional scoring system for the troponin component of HEART is as follows Troponin 99th percentile 0 in the case of Hstn T Roche 14ngl 99th percentile up to X3 URL 99th percentile 1 HSTN T 14-42ngL x3 URN 2 HSTN T 42ngl
the investigators previously defined that the optimal rule-out strategy for suspected acute coronary syndromes may well be a modified HEART score in a single centre study This study is to prospectively validate the use of this score in a prospective unselected cohort of patients with possible acute coronary syndrome at 2 large secondary care centres The second centre Royal Liverpool University Hospital was external to where the initial cohort of 1642 patients were assessed that defined modified HEART as the optimal score
The modified HEART score is as follows HEART score can be re-calibrated modified HEART to undetectable hstnT and 99th percentile limits 5 0 5-141 142
Troponin HSTnT Roche elecsys 14ngl 2 5-14ngl 1 5ngl 0
This 2 centre study will enrol consecutive patients with suspected acute coronary syndrome defined as physician suspicion of ischaemic chest pain resulting in sampling of High sensitive troponin and undertaking an electrocardiogram at presentation
For all troponin positive patients HSTnT14ngl the diagnosis will be adjudicated centrally with at least 2 blinded clinicians The outcome will be MACE at 6 weeks MACE will be defined by acute myocardial infarction urgent or emergency coronary revascularisation and all cause death
Power calculations provided by clinical trials university of Liverpool
Assuming
Prevalence of MACE events in the population with suspected ACS is 125 as in MACROS The anticipated sensitivity is 098 The acceptable value for the 95 confidence interval for sensitivity is 095 The power of the study is 80
Then the number of events needed would be approximately 150 Thus 1500125 1200 suspected ACS admission would need to be enrolled
The study has been assessed by research boards at both hospitals and has been registered as an audit with the primary aim of quality control of a novel accelerated chest pain pathway that has been recently implemented at both hospitals The study does not require individualised patient consent and is supported by the Caldicott Guardian
Secondary aims of the study are to compare the performance of modified HEART score with modified TIMI or equal to 1 or 0 and modified GRACE score or equal to 75 in terms of rule out for MACE at 6 weeks The investigators compare the performance of modified HEART with the use of undetectable HSTnT 5ngl combined with a nonischaemic ECG The latter is part of the recently adopted chest pain pathway at both recruiting hospitals with clear guidance of discharge at presentation for patients with chest pain who have an undetectable HSTnT and nonischaemic ECG Therefore it will allow the research team to compare modified HEART virtual discharge with actual rather than virtual discharge for an approach based on undetectable HSTnT
Detailed description
The HEART score as defined previously by Backus et al1 is a risk score specifically developed for acute chest pain suspected acute coronary syndrome The conventional scoring system for the troponin component of HEART is as follows Troponin 99th percentile 0 in the case of Hstn T Roche 14ngl 99th percentile up to X3 URL 99th percentile 1 HSTN T 14-42ngL x3 URN 2 HSTN T 42ngl
the investigators previously defined that the optimal rule-out strategy for suspected acute coronary syndromes may well be a modified HEART score in a single centre study This study is to prospectively validate the use of this score in a prospective unselected cohort of patients with possible acute coronary syndrome at 2 large secondary care centres The second centre Royal Liverpool University Hospital was external to where the initial cohort of 1642 patients were assessed that defined modified HEART as the optimal score
The modified HEART score is as follows HEART score can be re-calibrated modified HEART to undetectable hstnT and 99th percentile limits 5 0 5-141 142
Troponin HSTnT Roche elecsys 14ngl 2 5-14ngl 1 5ngl 0
This 2 centre study will enrol consecutive patients with suspected acute coronary syndrome defined as physician suspicion of ischaemic chest pain resulting in sampling of High sensitive troponin and undertaking an electrocardiogram at presentation
For all troponin positive patients HSTnT14ngl the diagnosis will be adjudicated centrally with at least 2 blinded clinicians The outcome will be MACE at 6 weeks MACE will be defined by acute myocardial infarction urgent or emergency coronary revascularisation and all cause death
Power calculations provided by clinical trials university of Liverpool
Assuming
Prevalence of MACE events in the population with suspected ACS is 125 as in MACROS The anticipated sensitivity is 098 The acceptable value for the 95 confidence interval for sensitivity is 095 The power of the study is 80
Then the number of events needed would be approximately 150 Thus 1500125 1200 suspected ACS admission would need to be enrolled
The study has been assessed by research boards at both hospitals and has been registered as an audit with the primary aim of quality control of a novel accelerated chest pain pathway that has been recently implemented at both hospitals The study does not require individualised patient consent and is supported by the Caldicott Guardian
Secondary aims of the study are to compare the performance of modified HEART score with modified TIMI or equal to 1 or 0 and modified GRACE score or equal to 75 in terms of rule out for MACE at 6 weeks The investigators compare the performance of modified HEART with the use of undetectable HSTnT 5ngl combined with a nonischaemic ECG The latter is part of the recently adopted chest pain pathway at both recruiting hospitals with clear guidance of discharge at presentation for patients with chest pain who have an undetectable HSTnT and nonischaemic ECG Therefore it will allow the research team to compare modified HEART virtual discharge with actual rather than virtual discharge for an approach based on undetectable HSTnT
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