To evaluate the efficacy of MBCT in comparison with treatment as usual (TAU) in women with MCDin terms of: reduction of psychological distress such as anxiety, depression and QOL, reduction of anginal symptoms, and improvement of vascular function
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subjective and objective improvement in women with MCD. This will be measured
by questionnaires, which the subjects will fill out themselves, and two
vascular measures.
Secondary outcome
not applicable
Background summary
The prognosis of women with persistant chest pain with non-obstructive CAD have
a worse prognosis when compared with asymptomatic women.
Recent research had revealed that particularly in this group of women,
microvascular coronary dysfunction (MCD), involving endothelial and
nonendothelial pathways, are important determinants for ischemia. Psychosocial
factors such as anxiety disorders are more often present in patients with MCD.
Almost 50% of patients with atypical chest pains have psychiatric co-morbidity.
The prognosis of woemn with angina pectoris due to non-obstructive CAD and MCD
has been shown to be less beneficial than previously considered.
Study objective
To evaluate the efficacy of MBCT in comparison with treatment as usual (TAU)
in women with MCDin terms of: reduction of psychological distress such as
anxiety, depression and QOL, reduction of anginal symptoms, and improvement of
vascular function
Study design
Exploratory pilot study in which we will randomize 40 female outpatients to
either MBCT or usual care
Intervention
Mindfulness-based cognitive therapy.
Study burden and risks
The intervention and the cardiovascular measures are low risk.
Geert Grootepleinzuid 10
Nijmegen 6500HB
NL
Geert Grootepleinzuid 10
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
Women 45-65 years old with recurrent angina pectoris for at least 3 months, in the absecen of obstructive CAD (as assessed by CAG or CCTA <1 year ago), who are normotensive (with/without medication) and have no structural heart disease (as detected by echocardiogram)
Exclusion criteria
Women outside of the age range, who are hypertensive and/or have a structural heart disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48476.091.14 |