RAPID-CTCA: Rapid Assessment of Potential Ischaemic Heart Disease With CTCA

Sponsor

University of Edinburgh (Other)

Overall Status

Unknown status

CT.gov ID

NCT02284191

Collaborator

NHS Lothian (Other)

1,749

Enrollment

Locations

Arms

69.1

Anticipated Duration (Months)

47.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Radiation: CT Coronary Angiogram	N/A

Detailed Description

DESIGN: Open parallel group randomised controlled trial of early computed tomography coronary angiography (CTCA) in patients presenting with suspected/confirmed acute coronary syndrome (ACS) to Emergency Departments (ED) and Medical Assessment Units.

SETTING: 37 EDs, radiology, cardiology and acute medical services in tertiary/district 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 e.g. ST segment depression >0.5 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: 1.Signs, 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 e.g. 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 µmol/L or estimated glomerular filtration rate <30 mL/min); Contrast allergy; Beta blocker intolerance (if no alternative heart rate limiting agent available/suitable) 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. 4.Previous recruitment to the trial; 5.Known pregnancy or currently breast feeding; 6. Inability to consent; 7.Further investigation for ACS would not in the patient's interest, due to limited life expectancy, quality of life or functional status; 8.Prisoners

HEALTH TECHNOLOGIES BEING ASSESSED: Early use of ≥64-slice CTCA as part of routine assessment compared to standard care.

MEASUREMENT OF COSTS/OUTCOMES: 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; 4.Coronary 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 4b);Subsequent 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 ACS/recurrent 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: 1,749 patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

1749 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

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.

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CT Coronary Angiogram CT Coronary Angiogram plus standard care	Radiation: CT Coronary Angiogram Completion of a CT Coronary Angiogram
No Intervention: Standard Care Standard care only

Arm

Intervention/Treatment

Active Comparator: CT Coronary Angiogram

CT Coronary Angiogram plus standard care

Radiation: CT Coronary Angiogram

Completion of a CT Coronary Angiogram

No Intervention: Standard Care

Standard care only

Outcome Measures

Primary Outcome Measures

The primary end-point will be all-cause death or subsequent non-fatal type 1 or type 4b MI at one year, measured as time to first such event. [1 year]
Myocardial infarction will be defined according to the most recent Universal Definition [Thygesen K, 2012] and will be adjudicated by two independent cardiologists blinded to the intervention.

Secondary Outcome Measures

Coronary Heart Disease (CHD) death or subsequent non-fatal MI [1 year]
Death or MI
Cardiovascular Disease (CVD) death or subsequent non-fatal MI [1 year]
CVD Death
Subsequent Non-fatal MI [1 year]
MI
Coronary Heart Disease death [1 year]
CHD Death
Cardiovascular death [1 year]
CVS Death
All-cause death [1 year]
Death
Coronary Heart Disease (CHD) death or subsequent non-fatal MI (type 1 or 4b) [1 year]
CHD and MI
Subsequent Non-fatal MI (type 1 or 4b) [1 year]
Non Fatal MI
Non-cardiovascular death [1 year]
Non CVS Death
Invasive coronary angiography [1 year]
Angiography procedures
Coronary revascularisation [1 year]
Revascularisation procedures
Percutaneous coronary intervention [1 year]
PCI interventions
Coronary artery bypass graft [1 year]
CABG procedures
Proportion of patients prescribed ACS therapies during index hospitalisation [1 year]
ACS therapies
Proportion of patients discharged on preventative treatment or have alteration in dosage of preventative treatment during index hospitalisation [1 year]
Preventative treatments
Length of Stay for Index Hospitalisation [1 year]
Length of Stay
Representation or rehospitalisation with suspected ACS/recurrent chest pain within 12 months after index hospitalisation [1 year]
Hospital attendances for ACS
Chest pain symptoms up to 12 months [1 year]
Patient symptoms measured by ROSE questionnaire
Quality of Life (measured by EQ-5D-5L up to 12 months) [1 year]
Quality of life measured by EQ-5D-5L questionnaire
Patient satisfaction at 1 month [1 year]
Participant questionnaire (11 questions) asking their viewpoint on the care they received during their baseline admission.
Clinician certainty of presenting diagnosis after CTCA [1 year]
Clinician certainty
Proportion of patients with alternative cardiovascular diagnoses identified on CTCA [1 year]
Safety assessment AE and SAEs
Proportion of patients with non-cardiovascular diagnosis identified on CTCA [1 year]
Safety Assessment AEs and SAEs
Radiation exposure from CTCA as trial intervention [1 year]
Safety Assessment AEs and SAEs
Cost effectiveness [1 year]
Estimated in terms of the lifetime incremental cost per quality-adjusted life year (QALY) gained.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA

Patient ≥18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of:

ECG abnormalities e.g. ST segment depression >0.5 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

Signs, 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 e.g. ST depression of >3 mm
Clinical team have scheduled early invasive coronary angiography on day of trial eligibility assessment.
Patient inability to undergo CT:
Severe renal failure (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min);
Contrast allergy;
Beta blocker intolerance (if no alternative heart rate limiting agent available/suitable) 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).
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.
Previous recruitment to the trial;
Known pregnancy or currently breast feeding;
Inability to consent;
Further investigation for ACS would not in the patient's interest, due to limited life expectancy, quality of life or functional status;
Prisoners

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Jersey General Hospital	St Helier	Jersey
2	Basildon and Thurrock University Hospitals NHS Foundation Trust	Basildon	United Kingdom
3	Ulster Hospital	Belfast	United Kingdom
4	Queen Elizabeth Hospital	Birmingham	United Kingdom
5	The Royal Bournemouth and Christchurch Hospital	Bournemouth	United Kingdom
6	Bradford Royal Infirmary	Bradford	United Kingdom
7	Russells Hall Hospital	Dudley	United Kingdom
8	Ninewells Hospital	Dundee	United Kingdom
9	Royal Infirmary Edinburgh	Edinburgh	United Kingdom	EH16 4SA
10	Glasgow Royal Infirmary	Glasgow	United Kingdom
11	Queen Elizabeth University Hospital	Glasgow	United Kingdom
12	Raigmore Hospital	Inverness	United Kingdom
13	Victoria Hospital	Kirkcaldy	United Kingdom
14	Leeds General Infirmary	Leeds	United Kingdom
15	University Hospital Lewisham	Lewisham	United Kingdom
16	Royal London Hospital	London	United Kingdom
17	St. Thomas' Hospital	London	United Kingdom
18	University Hospital North Tees	London	United Kingdom
19	Whipps Cross Hospital	London	United Kingdom
20	Luton & Dunstable Hospital	Luton	United Kingdom
21	Borders General Hospital	Melrose	United Kingdom
22	Milton Keynes University Hospital NHS Foundation Trust	Milton Keynes	United Kingdom
23	Royal Victoria Infirmary	Newcastle	United Kingdom
24	Derriford Hospital	Plymouth	United Kingdom
25	Queen Alexandra Hospital	Portsmouth	United Kingdom
26	Royal Berkshire NHS Foundation Trust	Reading	United Kingdom
27	East Surrey Hospital	Redhill	United Kingdom
28	Rotherham Hospital	Rotherham	United Kingdom
29	Sandwell General Hospital	Sandwell	United Kingdom
30	Northern General Hospital	Sheffield	United Kingdom
31	University Hospital Southampton NHS Foundation Trust	Southampton	United Kingdom
32	University Hospitals of the Midlands	Stoke	United Kingdom
33	Torbay Hospital	Torquay	United Kingdom
34	New Cross Hospital	Wolverhampton	United Kingdom
35	Worcestershire Royal Hospital	Worcester	United Kingdom
36	Wrexham Maelor Hospital	Wrexham	United Kingdom
37	University Hospital South Manchester	Wythenshawe	United Kingdom