Prevalence of patent foramen ovale (PFO) in patients with angina and documented coronary artery vasospasm

Recruiting

Conditions: Patent Foramen Ovale
10011082
10007510

Registration Number: NL-OMON51029

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Adult patients with documented coronary artery vasospasm with an
intracoronary acetylcholine provocation testing
- Able to measure oxygen saturation with a pulsoximeter
- Able to undergo TTE with agitated saline testing
- Able to perform Valsalva manoeuvre for reliable RLS assessment
- Able to undergo VO2max exercise testing

Exclusion Criteria

- Life expectancy < 1 year
- Active infection requiring antibiotic therapy, including endocarditis or
other disabling serious illness
- Absence of images of adequate quality with TTE due to anatomical reasons (*no
adequate TTE windows**)
- Inability to provide written informed consent
- Inability to comply with outpatient visit at hospital during 6 months
follow-up

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Prevalence of PFO and RLS in patients with documented coronary artery<br /><br>vasospasm (TTE with agitated-saline)<br /><br>- Quality of Life at baseline --> Seattle Angina Questionnaires (SAQ) score and<br /><br>Migraine Disability Assessment Questionnaire (MIDAS) score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Exercise testing in patients with coronary artery vasospasm and RLS<br /><br>- QoL during follow up<br /><br>- Number of episodes of angina symptoms will be assessed<br /><br>- Number of episodes of migraine headaches will be assessed<br /><br>- Association between exercise capacity, QoL and exercise-related oxygen<br /><br>(de)saturation in patients with coronary artery vasospasm and a RLS<br /><br>- Measurement of VO2 max during exercise testing<br /><br>- Measurement of oxygen saturation</p><br>