Tonometry(1) and duplex ultrasound(2) to predict cardiovascular events in to be treated patients with an abdominal aortic aneurysm

Recruiting

Conditions: Enlargement of the large blood vessel (aorta)/aneurysm
10082206
10002363

Registration Number: NL-OMON55391

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 194

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 infrarenal or juxtarenal abdominal aortic aneurysm (AAA), scheduled
for elective repair (i.e open repair, EVAR, FEVAR and CHEVAR) according to
standard practice

Exclusion Criteria

1. Life expectancy < 2 years;
2. Psychiatric or other condition that may interfere with the study;
3. Participating in another clinical study, interfering on outcomes;
4. Increased risk for coronary spasms (score Rose-questionnaire >=2);
5. Presence of Raynaud*s phenomenon, Marfan syndrome, chronic pain syndrome at
upper extremity(s), presence of an AV fistula or shunt, open wounds to the
upper extremity(s), and/or scleroderma associated with placing the hand in ice
water;
6. Recent (<3 months) presence of angina pectoris, myocardial infarction,
cerebral infarction, and/or heart failure, or PAD treatment.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the incidence of MACE during two year follow-up<br /><br>(Major adverse cardiovascular events (MACE); including myocardial infarction,<br /><br>cerebral infarction, heart failure, rupture, and peripheral vascular disease).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following secondary endpoints will be evaluated during the 2-year follow-up:<br /><br>- SMART risk score<br /><br>- CAR-test results;<br /><br>o Percentage of vasodilatation/vasoconstriction to the CAR-test at the common<br /><br>carotid artery at baseline.<br /><br>o Magnitude and timing of the blood flow and perfusion response<br /><br>o Blood pressure and heart rate responses<br /><br>o Changes after treatment<br /><br>- SphygmoCor parameters;<br /><br>o Peripheral pressure measurements (PWA)<br /><br>o Central and abdominal pressure parameters (derived using a transfer<br /><br>function) (PWA)<br /><br>o Cardiac output parameters (SEVR, ED) (PWA)<br /><br>o PWV<br /><br>o Changes after treatment<br /><br>- Score EQ-5D questionnaire<br /><br>- Score IPQ-K questionnaire</p><br>