To identify which patient characteristics and biomarkers can contribute to a better prediction of complications in patients with thoracic aortic disease. This will result in better risk-prediction with reassurance of low-risk individuals and…
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be increase in dimension of the aorta.
Secondary outcome
Secondary study parameters/endpoints are mortality, need for interventions and
complications (aortic dissection). Also the incidence of anxiety/depression and
the quality of life of patients and partners or family members will be
secondary endpoints.
Background summary
Thoracic aortic aneurysm (TAA) prevalence in the Netherlands is estimated at
200.000 adults, with annually 600 deaths of aortic dissection or rupture. To
prevent aortic dissection and sudden death, timely intervention is warranted.
The indication for preventive surgery is presently based on the underlying
diagnosis and aorta diameter. It is unknown to what extent biomarkers can
contribute to the selection of patients at high risk. Also in clinical practice
we experience anxiety and depression in patients with thoracic aortic disease
and their partners or family members with great impact on quality of life.
However, without objective evidence.
Study objective
To identify which patient characteristics and biomarkers can contribute to a
better prediction of complications in patients with thoracic aortic disease.
This will result in better risk-prediction with reassurance of low-risk
individuals and intensive follow-up with earlier surgical correction in
high-risk individuals. In addition we want to investigate the burden of anxiety
and depression in these individuals and their partners and family members to
see if this is indeed a problem and to identify possibilities for better
patient-tailored guidance and assistance.
Study design
A prospective, observational cohort study with invasive measurements (blood
samples) and three questionnaires.
Study burden and risks
For this study, blood samples (8 tubes, 46 mL blood) will be obtained ones.
Besides the blood sampling, patient and their partners or family members will
be asked to fill in the *Hospital Anxiety and Depression Scale* (HADS)
questionnaire, the Short Form (36) Health Survey (SF-36) and a disease-specific
questionnaire to investigate the impact of TAA on normal life. In 20 patients
we will perform an in-depth interview. All other investigations in this study
are part of routine clinical care. Therefore, risks for the patients can be
considered negligible.
s' Gravendijkwal 230
Rotterdam 3015CE
NL
s' Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
- Scheduled for an appointment at the outpatient department for thoracic aorta disease in the Erasmus MC
- Thoracic aorta pathology with or without known genetic mutation
- Receiving imaging of the aorta with use of echocardiography or computer tomography (CT)
- Capable of understanding and signing informed consent.
Exclusion criteria
- Patients who are not capable of understanding and signing informed consent.
- Age <18 years.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59759.078.17 |