Aortic Aneurysm, Abdominal
Conditions
Keywords
arterial stiffness, central hemodynamics
Brief summary
The purpose of this study is to evaluate by non-invasive methods the change in central hemodynamics and arterial stiffness produced by grafts and endografts after abdominal aortic aneurysm repair. Our main goal is to measure the changes in: Augmentation index, central blood pressure, pulse wave analysis, pulse wave velocity.
Detailed description
The measures will be done before the procedure and after them. We will use the device called: SphygmocoR (Atcor Medical, Sydney, Australia).
Interventions
OTHERnon-invasive methods
To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
Sponsors
Hospital Universitario Ramon y Cajal
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with diagnosis of abdominal aortic aneurysm requiring repair (open or endovascular) based on guidelines criteria for management.
Exclusion criteria
* Patients who don´t want to enter in the study. * Patients who don´t want to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aix@75 | Before surgery | Augmentation Index corrected to 75 bpm |
| AIx@75 | 2 months after Surgery | Augmentation Index corrected to 75 bpm |
Secondary
| Measure | Time frame |
|---|---|
| Central Blood Pressure | before surgery |
| Carotid Radial Pulse Wave Velocity | before surgery |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open-graft Group Patients treated for abdominal aortic aneurysm with open graft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure. | 19 |
| Endograft Group Patients treated for abdominal aortic aneurysm with endograft will be measured for central hemodynamics and arterial stiffness by non-invasive methods.
non-invasive methods: To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure. | 25 |
| Total | 44 |
Baseline characteristics
| Characteristic | Open-graft Group | Endograft Group | Total |
|---|---|---|---|
| Age, Continuous | 70.9 years STANDARD_DEVIATION 6.9 | 77.4 years STANDARD_DEVIATION 7.2 | 74.6 years STANDARD_DEVIATION 7.7 |
| Diameter AAA (mm) | 54 mm STANDARD_DEVIATION 5.1 | 63.2 mm STANDARD_DEVIATION 12.1 | 59.3 mm STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 18 Participants | 23 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 25 |
| other Total, other adverse events | 0 / 19 | 0 / 25 |
| serious Total, serious adverse events | 0 / 19 | 0 / 25 |
Outcome results
Primary
Aix@75
Augmentation Index corrected to 75 bpm
Time frame: Before surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-graft Group | Aix@75 | 31.8 percentage | Standard Deviation 8.9 |
| Endograft Group | Aix@75 | 32.5 percentage | Standard Deviation 7.7 |
Primary
AIx@75
Augmentation Index corrected to 75 bpm
Time frame: 2 months after Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-graft Group | AIx@75 | 29.3 percentage | Standard Deviation 7.5 |
| Endograft Group | AIx@75 | 28.4 percentage | Standard Deviation 9.2 |
Secondary
Carotid Radial Pulse Wave Velocity
Time frame: before surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-graft Group | Carotid Radial Pulse Wave Velocity | 7.99 cm/seg | Standard Deviation 1.44 |
| Endograft Group | Carotid Radial Pulse Wave Velocity | 8.41 cm/seg | Standard Deviation 1.6 |
Secondary
Carotid Radial Pulse Wave Velocity
Time frame: 2 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-graft Group | Carotid Radial Pulse Wave Velocity | 8.01 cm/seg | Standard Deviation 1.4 |
| Endograft Group | Carotid Radial Pulse Wave Velocity | 8.17 cm/seg | Standard Deviation 0.9 |
Secondary
Central Blood Pressure
Time frame: before surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-graft Group | Central Blood Pressure | 120.8 mmHg | Standard Deviation 17.8 |
| Endograft Group | Central Blood Pressure | 122.7 mmHg | Standard Deviation 16.1 |