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Advanced Cardiovascular Imaging of the Systemic Effects of Inflammasome Activation

Primary Purpose

Myocardial Infarction

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dapansutrile
Placebo
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

25 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dapansutrile

Control

Arm Description

Subjects randomized to receive oral dapnsutrile

Subjects randomized to receive oral placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2023
Last Updated
September 29, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05880355
Brief Title
Advanced Cardiovascular Imaging of the Systemic Effects of Inflammasome Activation
Official Title
Advanced Cardiovascular Imaging of the Systemic Effects of Inflammasome Activation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
October 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single blind study.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapansutrile
Arm Type
Experimental
Arm Description
Subjects randomized to receive oral dapnsutrile
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to receive oral placebo
Intervention Type
Drug
Intervention Name(s)
Dapansutrile
Intervention Description
Oral inhibitor of NLRP3
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Non-active placebo
Primary Outcome Measure Information:
Title
Remote plaque volume
Description
Carotid artery plaque volume change by ultrasound measured by 3D ultrasound. Outcome units will be cm3 averaged for bilateral carotid arteries.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Plaque inflammation
Description
Carotid artery plaque inflammatory activity by PET-CT. Units will be SVU averaged bilaterally for a region-of-interest over the carotid bifurcation.
Time Frame
3 months
Title
Coronary microvascular function
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan R Lindner, MD
Phone
4342979442
Email
jlindner@virginia.edu
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Advanced Cardiovascular Imaging of the Systemic Effects of Inflammasome Activation

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