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To assess the effects of endovascular aortic repair on cardiac morphology and function
After being informed about the study and potential risks, all patients giving written informed consent will undergo a pre-surgery evaluation: clinical evaluation, blood sampling, CT-scan, echocardiography and cardiac magnetic resonance.
The same evaluation will be performed at 6- and 12-months post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants submitted to aortic repair | Participants submitted endovascular repair of the aorta |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac magnetic ressonance | Diagnostic Test | In patients with aortic disease submitted to endovascular repair, will be studied through cardiac magnetic ressonance to evaluate cardiac function |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass with those obtained after a 12-month period. | The cardiac remodelling will be estimated through the variables of left ventricular mass at baseline and 12 months, measured in grams through CMR. | 12-month period |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass/volume/strain measurements with those obtained after a 6-month period. | The cardiac remodelling will be estimated through the variables of left ventricular mass/volume/strain at baseline and 6 months, measured in grams/mililiters/percentage through CMR and ECHO. | 6-month period |
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Inclusion Criteria:
- Patients over 18-year-old, with degenerative arch, descending thoracic or abdominal aortic aneurysms, penetrating aortic ulcers or intramural hematomas managed with total EVAR in elective setting.
Exclusion Criteria:
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We will include consecutive patients, >18 year-old, with degenerative arch, descending thoracic or abdominal aortic aneurysms (TAA), penetrating aortic ulcers (PAU) or intramural hematomas (IMH) managed with total endovascular aortic repair in elective setting.
We will exclude patients with heart failure with an ejection fraction <35 vs 50% or New York Heart Association (NYHA) class III and IV; LV wall motion abnormality; moderate to severe valve disease, history of (or expected within the study period) cardiac/aortic surgery; coronary artery disease; atrial fibrillation or congenital heart disease. Additionally, we will dismiss patients with connective tissue disorders, chronic kidney disease (eGFR <30 mL/min/173 m2), moderate to severe pulmonary disease as indicate either by post bronchodilator FEV1 (%predicted) <50% or Modified Medical Research Council Dyspnea Scale (mMRC) 3-4, and standard CMR contraindications (non-compatible pacemakers and metal implants, and claustrophobia).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Augusto Ministro Augusto Ministro | Contact | 00531 210405814 | cic@ulssm.min-saude.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade Local de Saúde Santa Maria | Recruiting | Lisbon | 1649-028 | Portugal |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001018 | Aortic Diseases |
| D004194 | Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
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blood samples
| To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular volume and strain measurements with those obtained after a 12-month period. | The cardiac remodelling will be estimated through the variables of left ventricular volume/strain at baseline and 12 months, measured in mililiters/percentage through CMR and ECHO. | 12-months period |
| To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline ECHO and CMR cardiac measurements with those obtained after 6- and 12-months periods. | The cardiac remodelling will be estimated through the variables of left ventricular mass/volume/strain at baseline, 6 months and 12 months, measured in grams/mililiters/percentage through CMR and ECHO. | 6- and 12-months periods |
| To correlate heart proximity and endograft extension with cardiac remodelling variables. | The cardiac remodelling will be correlated with the proximity and extension of aortic endografts, measured in milimeters, throught the analysis of the previously described cardiac remodelling variables and the analysis of CT scans. | 12-month period |
| To create a composite variable using cardiac biomarkers that correlate with cardiac remodelling variables at 6-months and 12-months | The cardiac biomarker will be obtained thorught blood sample analysis at 6-months and 12-months, comprised by the following: Soluble suppression of tumorigenicity-2 (sST2). Collagen synthesis biomarkers (PICP, PINP, PIIINCP, PIIINP). Collagen type I degradation biomarker (CITP). B-type natriuretic peptide and terminal of the prohormone brain natriuretic peptide (BNP, NT-proBNP). High sensitivity C Reactive protein (hsCRP). Galectin 3 (Gal3). Fibroblast activation protein (FAP). Troponins (I and T). Proteinomic and metabolomic parameters | 6-month and 12-month periods |
| To compare the agreement between measurements ECHO and CMR measurements. | 12-month period |
| To evaluate trends in the patient's blood pressure profile as a possible first sign of the hemodynamic changes induced by EVAR. | The patient's blood pressure will be evaluated in clinical visits at 1-month, 6 months and 12 months, mesured em mmHg. | 1-month, 6-months and 12-month period. |
| Unidade Local de Saúde de Santa Maria, E.P.E. | Not yet recruiting | Lisbon | Portugal |
| D013568 |
| Pathological Conditions, Signs and Symptoms |