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

May 30, 2025 updated by: Jonathan Lindner, MD, University of Virginia
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapansutrile
Subjects randomized to receive oral dapnsutrile
Drug: Dapansutrile
Oral inhibitor of NLRP3
Placebo Comparator: Control
Subjects randomized to receive oral placebo
Other: Placebo
Non-active placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 30, 2029

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR230183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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