Hypertrophic Obstructive Cardiomyopathy Clinical Trial
— TROPHIC 3Official title:
Mobilization of Endothelial Progenitor Cells Following Alcohol Septal Ablation in Hypertrophic Obstructive Cardiomyopathy: Randomized Controlled Trial of Aspirin
NCT number | NCT02674958 |
Other study ID # | 20150432 |
Secondary ID | |
Status | Terminated |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | April 1, 2022 |
Verified date | January 2023 |
Source | Ottawa Heart Institute Research Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aspirin at doses used during acute myocardial infarction may inhibit the mobilization of endothelial progenitor cells (EPCs).
Status | Terminated |
Enrollment | 6 |
Est. completion date | April 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Patients who have been selected to undergo alcohol septal ablation for hypertrophic obstructive cardiomyopathy based on clinical need 2. Age >18 years, <80 years Exclusion Criteria: 1. Patients with known allergy to aspirin 2. Inability or refusal to consent to participate in the study 3. Patients who are on non-steroidal anti-inflammatory drugs and cannot be stopped for the duration of the study |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Heart Institute Research Corporation |
Canada,
Chen TG, Chen JZ, Xie XD. Effects of aspirin on number, activity and inducible nitric oxide synthase of endothelial progenitor cells from peripheral blood. Acta Pharmacol Sin. 2006 Apr;27(4):430-6. doi: 10.1111/j.1745-7254.2006.00298.x. — View Citation
Etulain J, Fondevila C, Negrotto S, Schattner M. Platelet-mediated angiogenesis is independent of VEGF and fully inhibited by aspirin. Br J Pharmacol. 2013 Sep;170(2):255-65. doi: 10.1111/bph.12250. — View Citation
Lou J, Povsic TJ, Allen JD, Adams SD, Myles S, Starr AZ, Ortel TL, Becker RC. The effect of aspirin on endothelial progenitor cell biology: preliminary investigation of novel properties. Thromb Res. 2010 Sep;126(3):e175-9. doi: 10.1016/j.thromres.2009.11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Peak SDF-1 level | Change in level of SDF-1 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 | |
Other | Peak angiopoietin-1 level | Change in level of angiopoietin-1 at 0, 1, 6, 24, 72 hours and day 7 post procedure | 0 hour, 1 hour, 6 hours, 24 hours 72 hours and 7 days | |
Other | Peak angiopoietin-2 level | Change in level of angiopoietin-2 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 | |
Other | Peak tie-2 level | Change in level of tie-2 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 | |
Other | Peak vascular endothelial growth factor (VEGF) level | Change in level of VEGF 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 | |
Primary | 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 | 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 |
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