Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis

Launched by MASSACHUSETTS GENERAL HOSPITAL · Nov 14, 2024

Keywords

ClinConnect Summary

This clinical trial is examining whether a medication called canakinumab can help reduce inflammation in blood vessels for individuals who have a history of coronary artery disease, which includes having had a heart attack or a stent placed in their heart. The trial specifically looks at people who have certain genetic changes known as TET2 clonal hematopoiesis (CHIP) and those who do not have these changes. The main goal is to see if this drug can make a difference in managing vascular inflammation in these patients.

To participate in the study, individuals need to be at least 18 years old and have experienced a heart attack or had a stent placed more than 180 days before the study starts. However, there are several criteria that may prevent someone from joining, such as recent heart surgery or certain medical conditions. If eligible, participants will undergo imaging tests and may receive the medication to assess its effects. It’s important to note that the trial is not yet recruiting participants, so those interested will need to wait until it opens for enrollment.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 18 years or older
• • Prior heart attack or coronary stent procedure \>180 days before baseline imaging
• • Presence of either TET2 CHIP or no CHIP variants on prior sequencing
• Exclusion Criteria:
• • placement of a drug-eluting stent in a proximal coronary arterial segment \<180 days before baseline imaging
• • prior coronary artery bypass grafting
• • pregnancy or breastfeeding
• • history of blood malignancy or current solid-tumor malignancy
• • history of organ or stem cell transplantation
• • current treatment with prescription, systemic (oral, IV \[intravenous\], or IM \[intramuscular\]) steroids or anti-inflammatory/immune suppressant medical therapies (including colchicine but excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDS) for autoimmune/inflammatory diseases, post-transplant care, asthma, or pain
• • use of oral steroids or prescription oral anti-inflammatory/immune suppressant medication for \>7 days within the past 1 month
• • use of IV or IM steroids or IV or IM anti-inflammatory/immune suppressant medication within the past 3 months
• • known allergy to dextran's and/or DTPA and/or radiometals and/or severe allergy to iodinated contrast media
• • estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73 m2
• • contraindications to nitroglycerin known narrow angle glaucoma, or known severe aortic stenosis
• • use of phosphodiesterase type 5 inhibitor AND refusal to abstain from use of these medications within the 5 days prior to scheduled CCTA scan
• • significant radiation exposure (40msV) received within the past 12 months
• • concurrent enrollment in another research study judged by the investigators to interfere with the current study
• • known active or recurrent hepatic disease (including cirrhosis or ALT/AST levels \>3 times the upper limit oof or total bilirubin \>2 times the upper limits of normal)
• • history or evidence of tuberculosis (TB) (active or latent) infection or risk factor for TB
• • history of ongoing, chronic or recurrent infectious disease
• • suspected or proven immunocompromised state
• • live vaccinations within 3 months prior to randomization visit or live vaccinations planned during the trial