Aortic Disease, Cardiac Failure
Conditions
Keywords
cardiac, failure, aortic, disease
Brief summary
To assess the effects of endovascular aortic repair on cardiac morphology and function
Detailed description
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.
Interventions
DIAGNOSTIC_TESTcardiac magnetic ressonance
In patients with aortic disease submitted to endovascular repair, will be studied through cardiac magnetic ressonance to evaluate cardiac function
Sponsors
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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. * Congenital heart disease. * 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 Dyspnoea Scale (mMRC) 3-4. * CMR contraindications (non-compatible pacemakers and metal implants, and claustrophobia).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass with those obtained after a 12-month period. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 12-months 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. |
| 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. | 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. |
| To correlate heart proximity and endograft extension with cardiac remodelling variables. | 12-month period | 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. |
| To create a composite variable using cardiac biomarkers that correlate with cardiac remodelling variables at 6-months and 12-months | 6-month and 12-month periods | 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 |
| 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. | 1-month, 6-months and 12-month period. | The patient's blood pressure will be evaluated in clinical visits at 1-month, 6 months and 12 months, mesured em mmHg. |
Countries
Portugal
Contacts
CONTACTAugusto Ministro Augusto Ministro
Outcome results
None listed