Trial Outcomes & Findings for Rapid Assessment of Potential Ischaemic Heart Disease With CTCA (NCT NCT02284191)
NCT ID: NCT02284191
Last Updated: 2024-08-21
Results Overview
Number of participants categorised as having primary outcome event - all-cause death or subsequent non-fatal myocardial infarction (type 1 or 4b) at one year (post randomisation), measured as time to first such event. Myocardial infarction 'type' was defined according to the most recent Universal Definition (1). and was adjudicated independently by two cardiologists blinded to the intervention and the categorisation added to the study database.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1749 participants
Primary outcome timeframe
1 year (post randomisation)
Results posted on
2024-08-21
Participant Flow
1749 participants were enrolled into the study but only 1748 were available for analysis due to one participant requesting all their data be withdrawn from the dataset. Their randomisation allocation is unknown.
Participant milestones
| Measure |
CTCA Plus Standard Care
Computed tomography coronary angiogram plus standard care
|
Standard Care
Standard care only
|
|---|---|---|
|
Overall Study
STARTED
|
877
|
871
|
|
Overall Study
COMPLETED
|
875
|
868
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
CTCA Plus Standard Care
Computed tomography coronary angiogram plus standard care
|
Standard Care
Standard care only
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
|
Standard Care
n=871 Participants
Standard care only
|
Total
n=1748 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=877 Participants
|
0 Participants
n=871 Participants
|
0 Participants
n=1748 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
502 Participants
n=877 Participants
|
517 Participants
n=871 Participants
|
1019 Participants
n=1748 Participants
|
|
Age, Categorical
>=65 years
|
375 Participants
n=877 Participants
|
354 Participants
n=871 Participants
|
729 Participants
n=1748 Participants
|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 12.2 • n=877 Participants
|
61.2 years
STANDARD_DEVIATION 13.0 • n=871 Participants
|
61.6 years
STANDARD_DEVIATION 12.6 • n=1748 Participants
|
|
Sex: Female, Male
Female
|
313 Participants
n=877 Participants
|
321 Participants
n=871 Participants
|
634 Participants
n=1748 Participants
|
|
Sex: Female, Male
Male
|
564 Participants
n=877 Participants
|
550 Participants
n=871 Participants
|
1114 Participants
n=1748 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
858 participants
n=877 Participants
|
851 participants
n=871 Participants
|
1709 participants
n=1748 Participants
|
|
Region of Enrollment
Jersey
|
19 participants
n=877 Participants
|
20 participants
n=871 Participants
|
39 participants
n=1748 Participants
|
PRIMARY outcome
Timeframe: 1 year (post randomisation)Population: All randomised participants
Number of participants categorised as having primary outcome event - all-cause death or subsequent non-fatal myocardial infarction (type 1 or 4b) at one year (post randomisation), measured as time to first such event. Myocardial infarction 'type' was defined according to the most recent Universal Definition (1). and was adjudicated independently by two cardiologists blinded to the intervention and the categorisation added to the study database.
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event.
|
51 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants with coronary heart disease death or subsequent non-fatal myocardial infarction, one year after randomisation.
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Coronary Heart Disease Death or Subsequent Non-fatal MI
|
47 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants categorised as having cardiovascular disease death or subsequent non-fatal myocardial infarction, one year after randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Cardiovascular Disease Death or Subsequent Non-fatal MI
|
48 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants with subsequent non-fatal myocardial infarction, at one year post-randomisation.
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Subsequent Non-fatal MI
|
39 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants with Coronary Heart Disease deaths, one year after randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Coronary Heart Disease Death
|
11 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 year (post-randomisation)Number of participants with cardiovascular death, one year after randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Cardiovascular Death
|
12 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 year (post-randomisation)Number of participants with "all-cause" death, one year post-randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
All-cause Death
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants with Coronary heart disease death or subsequent non-fatal myocardial infarction (type 1 or 4b), one year after randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Coronary Heart Disease (CHD) Death or Subsequent Non-fatal MI (Type 1 or 4b)
|
43 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 1 year (post-randomisation)Number of participants with subsequent non-fatal myocardial infarction (type 1 or 4b), one year post randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Subsequent Non-fatal MI (Type 1 or 4b)
|
35 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 1 year (post-randomisation)Number of participants with non-cardiovascular deaths, one year post-randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Non-cardiovascular Death
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants with Invasive coronary angiography procedures, one year post-randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Invasive Coronary Angiography
|
474 Participants
|
530 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants with Coronary revascularisation by percutaneous coronary intervention or coronary artery bypass graft surgery, one year post randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Coronary Revascularisation
|
300 Participants
|
288 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants with percutaneous coronary interventions, 1 year (post randomisation)
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Percutaneous Coronary Intervention
|
260 Participants
|
240 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants with coronary artery bypass graft procedures, 1 year post randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Coronary Artery Bypass Graft
|
52 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants prescribed acute coronary syndrome therapies during index hospitalisation, 1 year (post randomisation)
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Number of Patients Prescribed ACS Therapies During Index Hospitalisation
|
595 Participants
|
580 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants discharged on preventative treatment having not been on preventative treatment prior to index hospitalisation, or alteration of dosage of preventative treatment during index hospitalisation, i.e. change in prevention treatment during index hospitalisation.
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Discharged on Preventative Treatment or Alteration in Dosage of Preventative Treatment During Index Hospitalisation
|
554 Participants
|
539 Participants
|
SECONDARY outcome
Timeframe: A maximum follow up of one-year post-randomisation.Length of Stay for Index Hospitalisation visit, measured in days each participants was hospitalised prior to their discharge. There is no maximum length an index hospitalisation might be for an individual participant, but follow up of participants is for a maximum one year.
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Length of Stay for Index Hospitalisation
|
2.2 days
Interval 1.1 to 4.1
|
2.0 days
Interval 1.0 to 3.8
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Number of participants who represented or were rehospitalised with suspected acute coronary syndrome/recurrent chest pain after discharge from index hospitalisation, up to one year after randomisation
Outcome measures
| Measure |
CT Coronary Angiogram
n=877 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
n=871 Participants
Standard care only
|
|---|---|---|
|
Representation or Rehospitalisation With Suspected ACS/ Recurrent Chest Pain After Index Hospitalisation
|
138 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: 1 year (post randomisation)Population: Standard care group do not get CT so there is no data to analyse
Median effective radiation dose (mSv) from CTCA received by participants in the CTCA arm of the study. Value derived from dose length product (mGy/cm) using conversion factor of 0.014 mSv/mGy/cm.
Outcome measures
| Measure |
CT Coronary Angiogram
n=767 Participants
CT Coronary Angiogram plus standard care
CT Coronary Angiogram: Completion of a CT Coronary Angiogram
|
Standard Care
Standard care only
|
|---|---|---|
|
Radiation Exposure From CTCA as Trial Intervention
|
3.1 mSv
Interval 1.9 to 5.5
|
—
|
Adverse Events
CT Coronary Angiogram
Serious events: 18 serious events
Other events: 3 other events
Deaths: 19 deaths
Standard Care
Serious events: 10 serious events
Other events: 0 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
CT Coronary Angiogram
n=877 participants at risk
CT Coronary Angiogram plus standard care
|
Standard Care
n=871 participants at risk
Standard care only
|
|---|---|---|
|
General disorders
Readmission with non-cardiac condition
|
0.68%
6/877 • Number of events 6 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
0.23%
2/871 • Number of events 2 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
|
General disorders
Readmission with chest pain - not CHD related
|
0.23%
2/877 • Number of events 2 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
0.46%
4/871 • Number of events 4 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
|
General disorders
Readmission with chest pain - CHD related
|
0.34%
3/877 • Number of events 3 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
0.23%
2/871 • Number of events 2 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
|
General disorders
Readmission with chest pain - unclear
|
0.11%
1/877 • Number of events 1 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
0.23%
2/871 • Number of events 2 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
|
General disorders
Not related - other
|
0.57%
5/877 • Number of events 5 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
0.00%
0/871 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
|
General disorders
Patient deterioration prior to CTCA
|
0.11%
1/877 • Number of events 1 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
0.00%
0/871 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
Other adverse events
| Measure |
CT Coronary Angiogram
n=877 participants at risk
CT Coronary Angiogram plus standard care
|
Standard Care
n=871 participants at risk
Standard care only
|
|---|---|---|
|
Surgical and medical procedures
IV cannula issue
|
0.34%
3/877 • Number of events 3 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
0.00%
0/871 • Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded
Serious Adverse Events related to endpoints collected and reported. Protocol defined AEs collected only: Contrast related anaphylaxis/allergy requiring treatment, critical care admission or resulting in cardiac arrest/ death, Contrast related AKI or Acute on CKD, Side effects related to beta blocker, HR-limiting medication or GTN.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place