N/A
N=1,748
Rapid Assessment of Potential Ischaemic Heart Disease With CTCA
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02284191 ↗Enrolled (actual)
1,748
Serious AEs
1.6%
Results posted
Aug 2024
Primary outcome: Primary: All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event. — 51; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CT Coronary Angiogram (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Edinburgh
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event. |
51; 53 | — |
| SECONDARY Coronary Heart Disease Death or Subsequent Non-fatal MI |
47; 45 | — |
| SECONDARY Cardiovascular Disease Death or Subsequent Non-fatal MI |
48; 46 | — |
| SECONDARY Subsequent Non-fatal MI |
39; 40 | — |
| SECONDARY Coronary Heart Disease Death |
11; 6 | — |
| SECONDARY Cardiovascular Death |
12; 8 | — |
| SECONDARY All-cause Death |
19; 17 | — |
| SECONDARY Coronary Heart Disease (CHD) Death or Subsequent Non-fatal MI (Type 1 or 4b) |
43; 43 | — |
| SECONDARY Subsequent Non-fatal MI (Type 1 or 4b) |
35; 38 | — |
| SECONDARY Non-cardiovascular Death |
7; 9 | — |
| SECONDARY Invasive Coronary Angiography |
474; 530 | — |
| SECONDARY Coronary Revascularisation |
300; 288 | — |
| SECONDARY Percutaneous Coronary Intervention |
260; 240 | — |
| SECONDARY Coronary Artery Bypass Graft |
52; 55 | — |
| SECONDARY Number of Patients Prescribed ACS Therapies During Index Hospitalisation |
595; 580 | — |
| SECONDARY Discharged on Preventative Treatment or Alteration in Dosage of Preventative Treatment During Index Hospitalisation |
554; 539 | — |
| SECONDARY Length of Stay for Index Hospitalisation |
2.2; 2.0 | — |
| SECONDARY Representation or Rehospitalisation With Suspected ACS/ Recurrent Chest Pain After Index Hospitalisation |
138; 130 | — |
| SECONDARY Radiation Exposure From CTCA as Trial Intervention |
3.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02284191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.