COMPLETE-2 V1.0
Research type
Research Study
Full title
A randomized trial of physiology-guided versus angiography-guided non-culprit lesion (NCL) complete revascularization strategies and a large-scale observational study of Optical Coherence Tomography in patients with acute myocardial infarction and multivessel coronary artery disease
IRAS ID
328136
Contact name
Helen Nguyen
Contact email
Sponsor organisation
Population Health Research Institute
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 5 months, 29 days
Research summary
People who have had a heart attack often receive stenting treatment of the narrowed heart blood vessel that caused the heart attack. Some people have narrowings in other heart arteries that require treatment at the same time. Heart doctors performing this treatment can either decide whether to treat these other arteries according to how severely narrowed they appear on the X-ray images or can insert a special wire into the narrowed blood vessel under X-ray screening then assess the impact of the narrowing on the pressure inside the blood vessel before deciding whether stenting is required. It is uncertain which of these methods is best and so this study involves randomising people to one or other decision-making method in order to see which is associated with the best outcomes. However, the severity of blood vessel narrowing and its impact on blood flow is not the only important factor in determining the risk related to the blood vessel narrowing since it is known that some narrowings are more prone to rupture and cause a heart attack. It is possible to use a special imaging probe to characterise the artery narrowing and this provides information that is complementary to the X-ray images. We will therefore perform a substudy of people for whom use of this special imaging probe is suitable and then relate the findings to clinical outcomes.
REC name
Wales REC 3
REC reference
23/WA/0207
Date of REC Opinion
16 Aug 2023
REC opinion
Further Information Favourable Opinion