Rapid Assessment of Potential Ischaemic heart Disease with Computed Tomography Coronary Angiography (CTCA)

Not Applicable

Completed

• Conditions: Emergency/Acute Medicine, Radiology, Cardiology; Circulatory System

• Registration Number: ISRCTN19102565
• Lead Sponsor: The University of Edinburgh (UK)

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27923390 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34588162/ results (added 04/10/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36062819/ HTA report (added 06/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-07
• Study Completion: 2020-06-30
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1748

Inclusion Criteria

Current inclusion criteria as of 19/01/2016:
Patients =18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of:
1. ECG abnormalities e.g. ST segment depression >0.5 mm
2. History of ischaemic heart disease (where the clinician assessing patient confirms history based on patient history or available records)
3. 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).

Previous inclusion criteria:
Patients aged 18 years or older with symptoms mandating investigation for suspected or confirmed ACS with at least one of:
1. ECG abnormalities e.g. ST segment depression >0.5 mm
2. History of ischaemic heart disease
3. Troponin elevation above the 99th centile of the normal reference range
(NB troponin assays will vary from site to site; local laboratory reference standards will be used).

Exclusion Criteria

Current exclusion criteria as of 19/01/2016:
1. Signs, symptoms, or investigations supporting high-risk ACS:
1.1. ST elevation MI
1.2. ACS with signs or symptoms of acute heart failure or circulatory shock
1.3. Crescendo episodes of typical anginal pain
1.4. Marked or dynamic ECG changes e.g. ST depression of >3 mm
1.5. Clinical team have scheduled early invasive coronary angiography on day of trial eligibility assessment
2. Patient inability to undergo CT:
2.1. Severe renal failure (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min)
2.2. Contrast allergy
2.3. Beta blocker intolerance (if no alternative heart rate limiting agent available/suitable) or allergy
2.4. Inability to breath hold
2.5. 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 breastfeeding
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

Previous 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
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; inability to hold breath; atrial fibrillation (mean heart rate greater than 75 beats per minute)
3. Invasive coronary angiography or CTCA within last 2 years if the previous investigation revealed CAD, 5 years if previous investigation normal
4. Previous recruitment to the trial
5. Known pregnancy
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified