Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI

Launched by UNIVERSITY OF VIRGINIA · May 19, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a specific treatment can affect heart health after a heart attack, specifically myocardial infarction (MI). Researchers will enroll patients who have had a heart attack and received urgent treatment to restore blood flow. Participants will be randomly assigned to either receive a medication called dapansutrile, which targets inflammation in the body, or a placebo (a harmless pill with no active ingredients). The main goal of the study is to see how this treatment influences the amount of plaque in the carotid arteries over six months, as well as how it affects inflammation and small blood vessel function in the heart.

To be eligible for this trial, participants need to be adults who have had a recent type I heart attack and either have plaque in their arteries or thickening of the artery walls. However, certain conditions would exclude someone from participating, such as severe heart failure, recent strokes, or certain allergies. Those who join the study can expect to have regular check-ups and tests over six months to monitor their heart health and the effects of the treatment. This trial is still in the planning stages and has not started recruiting participants yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Acute type I myocardial infarction (NSTEMI or STEMI)
• • Reperfusion therapy planned or performed within prior 48 hrs
• • Carotid or femoral artery plaque at baseline, or carotid intima media thickness \>1.5 mm
• Exclusion Criteria:
• • Type II MI
• • Failed primary PCI or need for emergent bypass surgery
• • Severe heart failure (NYHA class IV)
• • Life-threatening complication of MI (myocardial rupture, ischemic VSD, papillary muscle rupture)
• • Refractory ventricular arrhythmias
• • Allergy to dapansutril, OLT177, or drugs in the same class
• • Co-morbidity limiting 6 month survival
• • Active malignancy or recent malignancy with any systemic anti-cancer treatment
• • Active infection
• • Use of immunosuppressive medications or immunodeficiency disorder
• • Neutropenia (ANC \<2,000)
• • Moderate or severe renal impairment (GFR \<30 ml/min)
• • Recent stroke (within previous 3 months)
• • Allergy to ultrasound enhancing agents or polyethylene glycol
• • Pregnancy or breastfeeding