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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51029

Enrollment

100

Registered

2021-08-19

Start date

2021-10-12

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Patent Foramen Ovale

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Life expectancy

Design outcomes

Primary

Measure	Time frame
- Prevalence of PFO and RLS in patients with documented coronary artery vasospasm (TTE with agitated-saline) - Quality of Life at baseline --> Seattle Angina Questionnaires (SAQ) score and Migraine Disability Assessment Questionnaire (MIDAS) score	—

Secondary

Measure	Time frame
- 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	—

Measure

Time frame

- 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

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Countries

Netherlands

Outcome results