Table 3

Focus topic: contemporary multicentre strategy trials of cardiac imaging in patients with suspected stable IHD

TitleDesignResult
Published trials
PROMISE
NCT01174550
Aim: To compare CTCA versus standard care functional assessment
Setting: Hospitals in the USA
Sample size: 10 003
Primary endpoint: Death, MI, unstable angina
Compared with noninvasive functional testing, an initial strategy of CTCA did not improve clinical outcomes at a median follow-up of 2 years (primary endpoint event of 3.3% in the CTCA versus 3.0% in the noninvasive functional testing group)
SCOT-HEART
NCT01149590
Aim: Comparison of usual care to CTCA
Setting: Chest pain and cardiology clinics in hospitals in Scotland
Sample size: 4146
Primary endpoint: Death from coronary heart disease or nonfatal myocardial infarction at 5 years
Th primary endpoint was lower in the CTA group than in the standard care group (2.3% [48 patients] vs 3.9% (81 patients); HR, 0.59; 95% CI, 0.41 to 0.84; p=0.004
CE-MARC2
NCT01664858
Aim: To assess whether unnecessary invasive coronary angiograms are reduced using stress perfusion CMR at 3.0 Tesla versus MPS versus NICE guideline-directed care
Setting: Chest pain and cardiology clinics in hospitals in the UK
Sample size: 1202
Primary endpoint: Unnecessary invasive coronary angiography occurring within 12 months in each arm
The primary outcome occurred in 69 (28.8%) in the NICE guideline-directed group, and 36 (7.5%) and 34 (7.1%) in the CMR and MPS groups, respectively. There was a statistically significant lower adjusted OR of unnecessary angiography in the CMR versus NICE guideline-directed group (0.21, p<0.001), with no difference between the CMR or MPS group (1.27, p=0.32)
Trials yet to publish
ISCHEMIA
NCT01471522
Aim: To assess whether or not an initial invasive strategy of invasive angiography and optimal revascularisation if feasible, in addition to OMT in patients with stable CAD and at least moderate ischaemia on noninvasive ischaemia improves health outcomes compared with OMT alone
Setting: Hospitals worldwide
Sample size: 8000
Time to first occurrence of cardiovascular death or nonfatal myocardial infarction
DISCHARGE
NCT02400229
Aim: To evaluate whether CTCA-based management over invasive coronary angiography-guided care is superior in patients with stable angina and an intermediate pretest probability (10%–60%) of CAD
Setting: Hospitals in Europe
Sample size: 3546
Cardiovascular death, nonfatal myocardial infarction and nonfatal stroke at a maximum follow-up of 4 years.
FORECAST
NCT03187639
Aim: To assess whether routine FFR-CT is superior, in terms of resource utilisation, when compared with routine clinical pathway algorithms recommended by NICE
Setting: Single centre in the UK
Sample size: 1400
Resource utilisation at 9 months.
MR-INFORM
NCT01236807
Aim: To assess whether or not stress perfusion CMR is noninferior to invasive coronary angiography and FFR measurement for the management of patients with angina
Setting: Hospitals in the UK, Europe and Australia
Sample size: 918
Death, myocardial infarction and repeat coronary revascularisation at 1 year
CorCTCA
NCT03477890
Aim: To assess the prevalence of microvascular or vasospastic angina and the impact of invasive coronary artery function tests, in patients with nonobstructive CAD
Setting: Three hospitals in the UK
Sample size: 250
The between-group difference in the reclassification rate of the initial diagnosis following disclosure of invasive coronary artery function tests
  • CAD, coronary artery disease;CE-MARC2, Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2; CMR, Cardiac Magnetic Resonance; CTCA, CT coronary angiography;FFR, fractional flow reserve;IHD, ischaemic heart disease; MI, myocardial infarction;MPS, myocardial perfusion scintigraphy; NICE, National Institute of Health and Care Excellence; OMT, optimised medical therapy; PROMISE, progesterone in recurrent miscarriage; SCOT-HEART, Scottish COmputed Tomography of the HEART.