Status:
COMPLETED
Rapid Assessment of Potential Ischaemic Heart Disease With CTCA
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
NHS Lothian
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 (MA...
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 Emerge...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
1749 Patients enrolled
Trial Details
Trial ID
NCT02284191
Start Date
March 1 2015
End Date
December 1 2020
Last Update
August 21 2024
Active Locations (37)
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1
Jersey General Hospital
Saint 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