---
title: Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI
nct_id: NCT05880355
overall_status: NOT_YET_RECRUITING
phase: EARLY_PHASE1
sponsor: University of Virginia
study_type: INTERVENTIONAL
primary_condition: Myocardial Infarction
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05880355.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05880355"
ct_last_update_post_date: 2025-06-04
last_seen_at: "2026-05-12T07:32:33.714Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI

**NCT ID:** [NCT05880355](https://clinicaltrials.gov/study/NCT05880355)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** University of Virginia
- **Conditions:** Myocardial Infarction
- **Start Date:** 2026-04-01
- **Completion Date:** 2029-01-30
- **CT.gov Last Update:** 2025-06-04

## Brief Summary

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.

## Eligibility

- **Minimum age:** 25 Years
- **Maximum age:** 99 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Dapansutrile** (EXPERIMENTAL) — Subjects randomized to receive oral dapnsutrile
- **Control** (PLACEBO_COMPARATOR) — Subjects randomized to receive oral placebo

## Interventions

- **Dapansutrile** (DRUG) — Oral inhibitor of NLRP3
- **Placebo** (OTHER) — Non-active placebo

## Primary Outcomes

- **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

- **Plaque inflammation** _(time frame: 3 months)_
- **Coronary microvascular function** _(time frame: 3 months)_

## Locations (1)

- University of Virginia, Charlottesville, Virginia, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of virginia|charlottesville|virginia|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05880355.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05880355*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*