Rapid Assessment of Potential Ischaemic Heart Disease With CTCA

Acute Coronary Syndrome Clinical Trial

— RAPID-CTCA  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02284191
• Other study ID #: RAPID-CTCA-2014
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1749
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Radiation:
• CT Coronary Angiogram
Completion of a CT Coronary Angiogram

Locations

Country	Name	City	State
Jersey	Jersey General Hospital	St Helier
United Kingdom	Basildon and Thurrock University Hospitals NHS Foundation Trust	Basildon
United Kingdom	Ulster Hospital	Belfast
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	The Royal Bournemouth and Christchurch Hospital	Bournemouth
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Russells Hall Hospital	Dudley
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Royal Infirmary Edinburgh	Edinburgh
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Raigmore Hospital	Inverness
United Kingdom	Victoria Hospital	Kirkcaldy
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	University Hospital Lewisham	Lewisham
United Kingdom	Royal London Hospital	London
United Kingdom	St. Thomas' Hospital	London
United Kingdom	University Hospital North Tees	London
United Kingdom	Whipps Cross Hospital	London
United Kingdom	Luton & Dunstable Hospital	Luton
United Kingdom	Borders General Hospital	Melrose
United Kingdom	Milton Keynes University Hospital NHS Foundation Trust	Milton Keynes
United Kingdom	Royal Victoria Infirmary	Newcastle
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Queen Alexandra Hospital	Portsmouth
United Kingdom	Royal Berkshire NHS Foundation Trust	Reading
United Kingdom	East Surrey Hospital	Redhill
United Kingdom	Rotherham Hospital	Rotherham
United Kingdom	Sandwell General Hospital	Sandwell
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United Kingdom	University Hospitals of the Midlands	Stoke
United Kingdom	Torbay Hospital	Torquay
United Kingdom	New Cross Hospital	Wolverhampton
United Kingdom	Worcestershire Royal Hospital	Worcester
United Kingdom	Wrexham Maelor Hospital	Wrexham
United Kingdom	University Hospital South Manchester	Wythenshawe

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Countries where clinical trial is conducted

Jersey,  United Kingdom, 

Outcome

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

External Links

•   Protocol publication