Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02284191
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2014-10-06
Brief Title:
Rapid Assessment of Potential Ischaemic Heart Disease With CTCA
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
The Role of Early CT Coronary Angiography in the Evaluation Intervention and Outcome of Patients Presenting to the Emergency Department With Suspected or Confirmed Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
ACTIVE_NOT_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:
RAPID-CTCA
Brief Summary:
This study aims to investigate the effect of early CTCA in patients with suspected or confirmed Acute Coronary Syndrome ACS presenting to the Emergency Department ED or Medical Assessment Unit MAU upon interventions event rates and health care costs in a pragmatic clinical trial and economic evaluation up to 1 year after the trial intervention The primary objective will be to investigate the effect of the intervention on all-cause death or subsequent type 1 or type 4b MI at one year measured as time to first such event
Detailed Description:
DESIGN Open parallel group randomised controlled trial of early computed tomography coronary angiography CTCA in patients presenting with suspectedconfirmed acute coronary syndrome ACS to Emergency Departments ED and Medical Assessment Units
SETTING 37 EDs radiology cardiology and acute medical services in tertiarydistrict general National Health Service NHS hospitals
TARGET POPULATION Inclusion Criteria Patient 18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of ECG abnormalities eg ST segment depression 05 mm History of ischaemic heart disease where the clinician assessing patient confirms history based on patient history or available records Troponin elevation above the 99th centile of the normal reference range or increase in high sensitivity troponin meeting European Society of Cardiology criteria for rule-in or myocardial infarction NB troponin assays will vary from site to site local laboratory reference standards will be used Exclusion Criteria 1Signs symptoms or investigations supporting high-risk ACS ST elevation MI ACS with signs or symptoms of acute heart failure or circulatory shock Crescendo episodes of typical anginal pain Marked or dynamic ECG changes eg ST depression of 3 mm Clinical team have scheduled early invasive coronary angiography on day of trial eligibility assessment 2 Patient inability to undergo CT Severe renal failure serum creatinine 250 µmolL or estimated glomerular filtration rate 30 mLmin Contrast allergy Beta blocker intolerance if no alternative heart rate limiting agent availablesuitable or allergy Inability to breath hold Atrial fibrillation where mean heart rate is anticipated to be greater than 75 beats per minute after beta blockade 3 Patient has had invasive coronary angiography or CTCA within last 2 years and the previous investigation revealed obstructive coronary artery disease or patient had either investigation within the last 5 years and the result was normal 4Previous recruitment to the trial 5Known pregnancy or currently breast feeding 6 Inability to consent 7Further investigation for ACS would not in the patients interest due to limited life expectancy quality of life or functional status 8Prisoners
HEALTH TECHNOLOGIES BEING ASSESSED Early use of 64-slice CTCA as part of routine assessment compared to standard care
MEASUREMENT OF COSTSOUTCOMES Primary end-point will be one-year all-cause death or subsequent type 1 or type 4b MI at one year measured as time to first such event Secondary endpoints Key Secondary Endpoints 1 Coronary Heart Disease CHD death or subsequent non-fatal MI 2 Cardiovascular Disease CVD death or subsequent non-fatal MI 3 Subsequent non-fatal MI 4Coronary Heart Disease death 5 Cardiovascular death 6 All-cause death Other Endpoints Coronary
Heart Disease CHD death or subsequent non-fatal MI type 1 or 4bSubsequent Non-fatal MI type 1 or 4b Non-cardiovascular death Invasive coronary angiography Coronary revascularisation Percutaneous coronary intervention Coronary artery bypass graft Proportion of patients prescribed ACS therapies during index hospitalisation Proportion of patients discharged on preventative treatment or have alteration in dosage of preventative treatment during index hospitalisation Length of stay for index hospitalisation Representation or rehospitalisation with suspected ACSrecurrent chest pain within 12 months after index hospitalisation Chest pain symptoms up to 12 months Patient satisfaction at 1 month Clinician certainty of presenting diagnosis after CTCA Quality of Life measured by EQ- 5D-5L up to12 months Adverse Events and Serious Adverse Events Proportion of patients with alternative cardiovascular diagnoses identified on CTCA Proportion of patients with non-cardiovascular diagnosis identified on CTCA Radiation exposure from CTCA as trial intervention Cost effectiveness
Estimated in terms of the lifetime incremental cost per quality-adjusted life year QALY gained
SAMPLE SIZE 1749 patients 1748 available for analysis
SETTING 37 EDs radiology cardiology and acute medical services in tertiarydistrict general National Health Service NHS hospitals
TARGET POPULATION Inclusion Criteria Patient 18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of ECG abnormalities eg ST segment depression 05 mm History of ischaemic heart disease where the clinician assessing patient confirms history based on patient history or available records Troponin elevation above the 99th centile of the normal reference range or increase in high sensitivity troponin meeting European Society of Cardiology criteria for rule-in or myocardial infarction NB troponin assays will vary from site to site local laboratory reference standards will be used Exclusion Criteria 1Signs symptoms or investigations supporting high-risk ACS ST elevation MI ACS with signs or symptoms of acute heart failure or circulatory shock Crescendo episodes of typical anginal pain Marked or dynamic ECG changes eg ST depression of 3 mm Clinical team have scheduled early invasive coronary angiography on day of trial eligibility assessment 2 Patient inability to undergo CT Severe renal failure serum creatinine 250 µmolL or estimated glomerular filtration rate 30 mLmin Contrast allergy Beta blocker intolerance if no alternative heart rate limiting agent availablesuitable or allergy Inability to breath hold Atrial fibrillation where mean heart rate is anticipated to be greater than 75 beats per minute after beta blockade 3 Patient has had invasive coronary angiography or CTCA within last 2 years and the previous investigation revealed obstructive coronary artery disease or patient had either investigation within the last 5 years and the result was normal 4Previous recruitment to the trial 5Known pregnancy or currently breast feeding 6 Inability to consent 7Further investigation for ACS would not in the patients interest due to limited life expectancy quality of life or functional status 8Prisoners
HEALTH TECHNOLOGIES BEING ASSESSED Early use of 64-slice CTCA as part of routine assessment compared to standard care
MEASUREMENT OF COSTSOUTCOMES Primary end-point will be one-year all-cause death or subsequent type 1 or type 4b MI at one year measured as time to first such event Secondary endpoints Key Secondary Endpoints 1 Coronary Heart Disease CHD death or subsequent non-fatal MI 2 Cardiovascular Disease CVD death or subsequent non-fatal MI 3 Subsequent non-fatal MI 4Coronary Heart Disease death 5 Cardiovascular death 6 All-cause death Other Endpoints Coronary
Heart Disease CHD death or subsequent non-fatal MI type 1 or 4bSubsequent Non-fatal MI type 1 or 4b Non-cardiovascular death Invasive coronary angiography Coronary revascularisation Percutaneous coronary intervention Coronary artery bypass graft Proportion of patients prescribed ACS therapies during index hospitalisation Proportion of patients discharged on preventative treatment or have alteration in dosage of preventative treatment during index hospitalisation Length of stay for index hospitalisation Representation or rehospitalisation with suspected ACSrecurrent chest pain within 12 months after index hospitalisation Chest pain symptoms up to 12 months Patient satisfaction at 1 month Clinician certainty of presenting diagnosis after CTCA Quality of Life measured by EQ- 5D-5L up to12 months Adverse Events and Serious Adverse Events Proportion of patients with alternative cardiovascular diagnoses identified on CTCA Proportion of patients with non-cardiovascular diagnosis identified on CTCA Radiation exposure from CTCA as trial intervention Cost effectiveness
Estimated in terms of the lifetime incremental cost per quality-adjusted life year QALY gained
SAMPLE SIZE 1749 patients 1748 available for analysis
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