Table 3.
Focus topic: contemporary multicentre strategy trials of cardiac imaging in patients with suspected stable IHD
Title | Design | Result |
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.