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The goal of this clinical trial is to learn if icosapent ethyl (Vascepa) works to lessen the amount of inflammation in adults diagnosed with Community-Acquired Pneumonia (CAP). The main question it aims to answer is:
What is the effect of taking Vascepa on inflammation in the arteries in patients with CAP? Researchers will compare the drug Vascepa to a placebo (a look-alike submstance that contains no drug) to see if Vascepa works to reduce inflammation in patients with CAP.
Participants wil:
TIN CAP is a multi centre, prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the use of icosapent ethyl (Vascepa) on vascular inflammation in patients with CAP using FDG-PET/CT imaging and measurement of circulating biomarkers. The current proposal uses a randomized design to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants randomized to this arm will receive Vascepa for 6 months. |
|
| Placebo | Placebo Comparator | Participants randomized to this arm will receive placebo for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] | Drug | Participants randomized to the treatment arm will receive Vascepa 1000mg twice a day for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change over 6 months in the FDG uptake TBR as a marker of arterial plaque inflammation between the icosapent ethyl and placebo groups | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The change in inflammation, measured on FDG PET, in the pulmonary tissue. | The change in background-corrected measure of total metabolic activity (total pulmonary glycolytic activity) will be measured. | 6 months |
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Inclusion Criteria:
Patients who have:
Exclusion Criteria:
Patients who have:
Exclusion for CTA portion of the protocol:
Patients with dye allergy will not undergo CTA but will have PET/CT
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Boczar, MD | Contact | 1-613-696-7000 | kboczar@ottawaheart.ca | |
| Ashley Cowan, BScN | Contact | 1-613-696-7000 | acowan@ottawaheart.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Boczar, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41781043 | Derived | Stotts C, Corrales-Medina VF, deKemp RA, Wells GA, Beanlands R, Raggi P, Ferrara G, Sligl W, A Connelly K, Paul N, Brouwers M, Contreras-Dominguez V, Yadav K, Torres C, Tavoosi A, Wiefels C, Kirpalani A, Romsa JG, Grey B, Deva D, Rayner K, Boczar KE. Targeting Vascular Inflammation In Patients with Community-Acquired Pneumonia (TIN-CAP): protocol for a multicentre, randomised, double-blind, placebo-controlled trial. BMJ Open. 2026 Mar 4;16(3):e114239. doi: 10.1136/bmjopen-2025-114239. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D000098968 | Community-Acquired Pneumonia |
| D017714 | Community-Acquired Infections |
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| C035276 | eicosapentaenoic acid ethyl ester |
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| Placebo | Drug | Placebo twice daily |
|
| D012141 |
| Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D020763 | Pathological Conditions, Anatomical |