Residual Inflammation and Plaque Progression Long-term Evaluation (RIPPLE)

University of Cambridge

Status

Active, not recruiting

Conditions

Coronary Artery Disease

Inflammation

Myocardial Infarction

Atherosclerosis

Treatments

Diagnostic Test: Cardiac MRI

Diagnostic Test: PET imaging

Diagnostic Test: Coronary CT angiography

Study type

Observational

Funder types

Other

Identifiers

NCT04073810

A095007 (RIPPLE)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female participants >18 years old
Able to give written, informed consent and to lie flat
First-presentation of myocardial infarction within ~2 weeks
At least mild non-culprit coronary artery disease on angiography, managed medically

Exclusion criteria

Women of child bearing potential not using adequate contraception
Contrast allergy or contrast-nephropathy
Uncontrolled atrial fibrillation
Chronic kidney disease (eGFR <30 mL/min/1.73 m2)
Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
Uncontrolled chronic inflammatory disorder
History of recent malignancy deemed relevant to the study by the investigator
Current use of systemic corticosteroids
Previous coronary artery bypass grafting surgery (CABG) or percutaneous coronary intervention (PCI) before the index event
Contraindication to coronary angiography
Requires CABG or staged non-culprit artery PCI