The main objective of this study is to assess the prevalence of PFO and RLS in patients with angina and documented coronary artery vasospasm.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 outcome
- 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
Background summary
Patent Foramen Ovale (PFO) and atrial septal defect (ASD) have been associated
with the occurrence of paradoxical embolism. Current guidelines and position
reports recommend diagnostic work-up in young patients with cryptogenic stroke
and closure of PFO in selected cases. In addition to the association between
PFO and cryptogenic stroke, there are many reports of patients with a PFO that
suffer a systemic arterial embolism causing arterial occlusion of extremities,
renal infarcts and acute myocardial infarction with paradoxical embolism in the
coronary artery.
In addition, PFO has been associated with migraine with aura, suggesting that
vaso-active components of the venous circulation, when bypassing the lungs
through a right-to-left-shunt (RLS), may modulate the cerebral microcirculation
causing migraine. Although recent randomized trials have not demonstrated that
PFO closure is superior to medical therapy in migrainers, PFO closure has been
shown to abolish migraine in 9% of patients and reduce the number of monthly
migraine days with 3 days in a recent meta-analysis.
In a recent study, an association was demonstrated between migraine and
coronary spasm, although there was no association with coronary heart disease
(CHD) events. Importantly, anti-migraine medication such as triptans may cause
coronary spasm. RLS can be a trigger for the occurrence of migraine headaches
and is postulated to be a trigger for episodes of angina complaints due to
coronary spasm.
Study objective
The main objective of this study is to assess the prevalence of PFO and RLS in
patients with angina and documented coronary artery vasospasm.
Study design
This is a single-center, prospective, cohort study. Open label with follow up
at 6 months.
Study burden and risks
After signing informed consent, patients will undergo transthoracic
echocardiography (TTE) with intravenous agitated-saline to evaluate the
presence of RLS. Patients with a PFO and RLS will be invited to undergo
exercise testing including VO2max and oxygen saturation measurement. Patients
will be surveyed with the Seattle Angina Questionnaires (SAQ) and Migraine
Disability Assessment Questionnaire (MIDAS). They will report general
well-being, daily activities, and episodes of angina and migraine. Patients
with RLS will be asked to measure oxygen saturation with a pulsoximeter at set
intervals during the follow-up period, e.g. before and during exercises.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL78011.018.21 |
OMON | NL-OMON27068 |