Mobilization of Endothelial Progenitor Cells and Aspirin

Study Overview
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Brief Summary
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Aspirin at doses used during acute myocardial infarction may inhibit the mobilization of endothelial progenitor cells (EPCs).

Detailed Description
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Aspirin has been shown to lower the number of EPCs in a time- and concentration-dependent manner. In vitro studies also show that aspirin may reduce the migratory and adhesive capacity of isolated EPCs, inhibit iNOS and tubule formation, which are pre-requisites for angiogenesis. This is relevant when patients are given a loading dose of 325mg at the time of diagnosis of acute myocardial infarction where higher numbers of EPCs have been associated with better outcomes. Furthermore, in the PLATO (Platelet Inhibition and Patient Outcomes) trial, high dose aspirin appeared to counteract the beneficial effect seen when ticagrelor or clopidogrel was used with low doses of aspirin in acute coronary syndromes (ACS). As aspirin is currently standard of care in the management of ACS, it is difficult to conduct a study of the effect of aspirin versus placebo in that scenario. However, during alcohol septal ablation for hypertrophic obstructive cardiomyopathy, the indication for an antiplatelet agent is not well defined and varies between operators. When a small amount of myocardium is deliberately destroyed in this process, it serves as an ideal model to study the effect of aspirin on the biology of EPCs in vivo. This could provide an explanation to the different effects of high versus low dose aspirin when combined with a second antiplatelet agent in the management of ACS.

Official Title
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Mobilization of Endothelial Progenitor Cells Following Alcohol Septal Ablation in Hypertrophic Obstructive Cardiomyopathy: Randomized Controlled Trial of Aspirin

Conditions
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Hypertrophic Obstructive Cardiomyopathy

Intervention / Treatment
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* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been selected to undergo alcohol septal ablation for hypertrophic obstructive cardiomyopathy based on clinical need Age >18 years, <80 years Exclusion Criteria: Patients with known allergy to aspirin Inability or refusal to consent to participate in the study Patients who are on non-steroidal anti-inflammatory drugs and cannot be stopped for the duration of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin<br>Aspirin 325mg orally bolus followed by 162mg orally daily during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7. | Drug: Aspirin<br>* Aspirin 325mg bolus followed by 162mg daily until day 7 post alcohol septal ablation<br>* Other names: Acetylsalicylic acid;|
| No Intervention: No aspirin<br>No aspirin allowed during alcohol septal ablation for hypertrophic obstructive cardiomyopathy until day 7. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum circulating endothelial progenitor cells as a ratio to baseline at any timepoint | Change in number of EPCs measured at 0 (baseline), 1, 6, 24, 72 hours and on day 7 post procedure | 0 hour, 1 hour, 6 hours, 24 hours, 72 hours and 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell migration in vitro compared to baseline at any timepoint | Change in endothelial migration measured at 0,1, 6, 24, 72 hours and on day 7 post procedure | 0 hour, 1 hour, 6 hours, 24 hours, 72 hours and 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial progenitor cells, aspirin, acetylsalicylic acid, alcohol septal ablation