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NCT Number: NCT05880355

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

Subjects with urgently reperfused type I myocardial infarction (MI) will be recruited and randomized to receive either placebo or the oral inflammasome (NLRP3) inhibitor dapansutrile. The primarily outcome measure will be carotid plaque volume change over 6 months; secondary outcome measures will be plaque inflammatory activity and coronary microvascular function.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

25 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapansutrile

Drug

Oral inhibitor of NLRP3

Placebo

Other

Non-active placebo

Primary outcomes

  1. Remote plaque volume

    Time frame: 6 months

    Carotid artery plaque volume change by ultrasound measured by 3D ultrasound. Outcome units will be cm3 averaged for bilateral carotid arteries.

Secondary outcomes

  1. Plaque inflammation

    Time frame: 3 months

    Carotid artery plaque inflammatory activity by PET-CT. Units will be SVU averaged bilaterally for a region-of-interest over the carotid bifurcation.

  2. Coronary microvascular function

    Time frame: 3 months

    Coronary microvascular reactivity by myocardial contrast echo (MCE) quantitative perfusion imaging. The primary endpoint unit will be coronary microvascular flux rate reserve (regadenoson stress: rest ratio).

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan R Lindner, MD

CONTACT

[email protected]

4342979442

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 30, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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