Last updated on October 2018

Rapid Assessment of Potential Ischaemic Heart Disease With CTCA

Brief description of study

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 the proportion of patients with all-cause death or recurrent non-fatal type 1 or type 4b myocardial infarction (MI) at one year.

Detailed Study 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 mol/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 recurrent type 1 or type 4b MI at one year, measured as time to such event. Secondary endpoints: Secondary endpoints: 1. Hospital length of stay, coronary care length of stay; 2. Proportion of patients receiving invasive coronary angiography during index hospitalisation; 3. Proportion of patients receiving coronary revascularisation during index hospitalisation; 4. Proportion of patients receiving subsequent unplanned coronary revascularisation after index hospitalisation; 5. Proportion of patients receiving invasive coronary angiography despite no significant lesion on CTCA; 6. Proportion of patients assigned to CTCA with obstructive or nonobstructive disease; 7. Proportion of patients prescribed ACS therapies during index hospitalisation; 8. Proportion of patients discharged on prevention treatment or have alteration in dosage of prevention treatment during index hospitalisation; 9. Rehospitalisation/presentation with chest pain within 12 months; 10. Patient symptoms and quality of life up to 12 months; 11. NHS resource utilisation; 12. Patient satisfaction; 13. Clinician certainty of presenting diagnosis after CTCA. Safety: 1. Proportion of patients with allergy/anaphylaxis/acute kidney injury; 2. Proportion of patients with alternative diagnoses that relates to presentation on CTCA e.g. aortic dissection or pulmonary embolus; 3. Proportion of patients with incidental finding but potentially concerning on CTCA e.g. malignancy or pulmonary nodules; 4. Total average radiation exposure from CTCA in the intervention arm during index hospitalisation. Cost effectiveness: Estimated in terms of the lifetime incremental cost per quality-adjusted life year (QALY) gained.

SAMPLE SIZE: 1,735 patients.

Clinical Study Identifier: NCT02284191

Contact Investigators or Research Sites near you

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Kat Oatey

Luton & Dunstable Hospital
Luton, United Kingdom
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Recruitment Status: Open

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