Cardiac Remodelling Following Endovascular Repair of the Aorta
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cardiac magnetic ressonance.
- Who it may be relevant to
- Registry conditions: Cardiac Failure, Aortic Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test cardiac magnetic ressonance
In patients with aortic disease submitted to endovascular repair, will be studied through cardiac magnetic ressonance to evaluate cardiac function
Primary outcome measures
- To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass with those obtained after a 12-month period. [Time frame: 12-month period]
Secondary outcome measures (7)
- 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. [Time frame: 6-month period]
- 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. [Time frame: 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. [Time frame: 6- and 12-months periods]
- To correlate heart proximity and endograft extension with cardiac remodelling variables. [Time frame: 12-month period]
- To create a composite variable using cardiac biomarkers that correlate with cardiac remodelling variables at 6-months and 12-months [Time frame: 6-month and 12-month periods]
- To compare the agreement between measurements ECHO and CMR measurements. [Time frame: 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. [Time frame: 1-month, 6-months and 12-month period.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Portugal · 2 centers
- Unidade Local de Saúde Santa Maria — Lisbon
- Unidade Local de Saúde de Santa Maria, E.P.E. — Lisbon
Identifiers
NCT: NCT07415447 · 2023.15211.PEX