Prevalence of patent foramen ovale (PFO) in patients with angina and documented coronary artery vasospasm
- Conditions
- <p>Patent foramen ovale (PFO)Coronary artery vasospasm</p>
- Registration Number
- NL-OMON27068
- Lead Sponsor
- Investigator initiated study, Sponsor AUMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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 at the outpatient clinic
- 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 non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Prevalence of PFO and RLS in patients with documented coronary artery vasospasm - QoL, SAQ score and MIDAS score</p>
- Secondary Outcome Measures
Name Time Method <p>- Exercise testing in patients with coronary artery vasospasm and RLS - QoL during follow up - Number of episodes of angina symptoms will be assessed - Number of episodes of migraine headaches will be assessed - Association between exercise capacity, QoL and exercise-related oxygen (de)saturation in patients with coronary artery vasospasm and a RLS - Measurement of VO2 max during exercise testing - Measurement of oxygen saturation</p>