Tonometry (1) and duplex ultrasound (2) to predict Abdominal Aorta Aneurysm (3) progression and cardiovascular events in aneurysm patients

Tonometry (1) and duplex ultrasound (2) to predict Abdominal Aorta Aneurysm (3) progression and cardiovascular events in aneurysm patients - 1-2-3 Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48372

Enrollment

167

Registered

2019-05-16

Start date

2019-07-25

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enlargement of the large blood vessel (aorta)/aneurysm

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male or female at least 18 years old; 2. Informed consent form understood and signed and patient agrees to follow-up visits; 3. Has an abdominal aortic aneurysm (AAA), who is still under surveillance;

Exclusion criteria

Exclusion criteria: 1. Life expectancy

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the incidence of MACE during two year follow-up (Major adverse cardiovascular events (MACE); including myocardial infarction, cerebral infarction, heart failure, and peripheral vascular disease).	—

Secondary

Measure	Time frame
The following secondary endpoints will be evaluated during the 2-year follow-up: - SMART risk score; - SphygmoCor parameters; o Peripheral pressure measurements (PWA) o Central and abdominal pressure parameters (derived using a transfer function) (PWA) o Cardiac output parameters (SEVR, ED) (PWA) o PWV -CAR-test results; o Percentage of vasodilatation/vasoconstriction to the CAR-test at the common carotid artery at baseline. o Magnitude and timing of the blood flow and perfusion response o Blood pressure and heart rate responses -AAA progression (in mm/year); -AAA repair; -AAA Rupture; -Any other (S)AE ; -Score EQ-5D questionnaire -Score IPQ-K questionnaire	—

Measure

Time frame

The following secondary endpoints will be evaluated during the 2-year follow-up: - SMART risk score; - SphygmoCor parameters; o Peripheral pressure measurements (PWA) o Central and abdominal pressure parameters (derived using a transfer function) (PWA) o Cardiac output parameters (SEVR, ED) (PWA) o PWV -CAR-test results; o Percentage of vasodilatation/vasoconstriction to the CAR-test at the common carotid artery at baseline. o Magnitude and timing of the blood flow and perfusion response o Blood pressure and heart rate responses -AAA progression (in mm/year); -AAA repair; -AAA Rupture; -Any other (S)AE ; -Score EQ-5D questionnaire -Score IPQ-K questionnaire

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Countries

Netherlands

Outcome results