NCT04073810

Residual Inflammation and Plaque Progression Long-term Evaluation

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Inflammation drives atherosclerotic plaque rupture triggering most acute coronary syndromes. Despite advances in diagnosis and management of atherosclerosis, patients with myocardial infarction (MI) remain at increased risk of recurrent events. The RIPPLE study aims to examine the relationship between residual coronary inflammation detected by 68Ga-DOTATATE PET in patients treated for MI to long-term plaque progression measured by CT coronary angiography (CTCA). The association between infarct-related myocardial 68Ga-DOTATATE PET and myocardial function and viability will also be assessed.

Detailed description

While vascular inflammation can be detected using 18F-FDG PET, this method lacks inflammatory cell specificity and is unreliable for coronary imaging because of high background signals from the myocardium. Upregulation of somatostatin receptor subtype-2 (SST2) occurs in activated macrophages, offering a novel inflammation imaging target. 68Ga-DOTATATE, an SST2 PET tracer with low myocardial binding, shows promise for imaging coronary inflammation. Having previously demonstrated increased 68Ga-DOTATATE signals in coronary atherosclerotic lesions post-MI, we now aim to study the natural history of residual arterial inflammation in non-culprit arteries and better understand how 68Ga-DOTATATE signals relate to plaque morphology, progression and rupture. Residual infarct-related myocardial inflammation and its association with ischemic myocardial remodelling will also be examined.

Conditions

• Atherosclerosis
• Myocardial Infarction
• Coronary Artery Disease
• Inflammation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PET imaging	Coronary 68Ga-DOTATATE PET-MRI or PET-CT at baseline and 3 months
DIAGNOSTIC_TEST	Coronary CT angiography	CTCA at baseline and 2 years
DIAGNOSTIC_TEST	Cardiac MRI	Cardiac MRI at 1 year

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-12-01
• Completion: 2025-04-01
• First posted: 2019-08-29
• Last updated: 2024-07-19

Locations

1 site across 1 country: United Kingdom