Cerebrovascular Accident Clinical Trial
— RETORICOfficial title:
Rule Out Transcatheter Aortic Valve Thrombosis With Post Implantation Computed Tomography
The RETORIC study is a prospective cohort study with a primary aim to assess the incidence
and independent predictors of reduced leaflet motion and valve thrombosis after TAVI
procedure using multimodality imaging strategy comprising cardiac CT, transesophageal
echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will
assess the incidence of stroke and transient ischemic attack (TIA) in patients with reduced
leaflet motion and/or thrombosis when compared with those with normal leaflet function. In
addition we will randomize patients with reduced leaflet motion and/or valve thrombosis to
single antiplatelet therapy plus oral anticoagulation therapy versus standard therapy.
The primary outcome of the nested randomized trial will be the presence of reduced leaflet
motion and/or valve thrombosis after 4 months, the secondary outcome is the presence of
ischemic changes in brain demonstrated by MRI.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 2019 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - TAVI procedure - Signed ethics committee-approved informed consent form Exclusion Criteria: - Age under 18 years - Patients for whom multidetector-row computed tomography is contraindicated per institutional standard of care (History of severe and/or anaphylactic contrast reaction, severe renal insufficiency, inability to cooperate with scan acquisition and/or breathhold instructions) - Patients diagnosed with infective endocarditis since TAVI procedure |
Country | Name | City | State |
---|---|---|---|
Hungary | Heart and Vascular Center, Semmelweis University | Budapest |
Lead Sponsor | Collaborator |
---|---|
Semmelweis University Heart and Vascular Center |
Hungary,
Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, de Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Søndergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduced leaflet motion and/or valve thrombosis | 4 months | ||
Secondary | Presence of ischemic brain lesions | Presence of ischemic brain lesions demonstrated by MRI | 4 months |
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