Advanced Cardiovascular Imaging of the Systemic Effects of Inflammasome Activation

Myocardial Infarction Clinical Trial

Official title:

Advanced Cardiovascular Imaging of the Systemic Effects of Inflammasome Activation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05880355
• Other study ID #: HSR230183
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: January 1, 2024
• Est. completion date: October 30, 2028

Study information

• Verified date: September 2023
• Source: University of Virginia
• Contact: Jonathan R Lindner, MD
• Phone: 4342979442
• Email: jlindner[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 30, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Dapansutrile
Oral inhibitor of NLRP3

Other:
• Placebo
Non-active placebo

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remote plaque volume	Carotid artery plaque volume change by ultrasound measured by 3D ultrasound. Outcome units will be cm3 averaged for bilateral carotid arteries.	6 months
Secondary	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.	3 months
Secondary	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).	3 months