The current research proposal therefore aims to examine the relation between a range of psychological risk factors and several mental stress-induced physiological responses in a large sample of PCI patients.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Predictors: Psychological risk factors (depression, anxiety, Type D
personality, mindfulness);
Outcome variables: hormonal (cortisol), hemodynamic (blood pressure, cardiac
output), and myocardial (pre-ejection period, heart rate variability, heart
rate) stress reactivity.
Secondary outcome
complications, events and death at 1 year after PCI
Background summary
Psychological risk factors such as depression, anxiety and Type D personality
have a negative impact on prognosis in cardiac patients. However, to date it is
still unclear through which mechanisms psychological risk factors exert this
effect, and whether the same mechanisms apply for all or that there are
differential mechanisms at play.
Study objective
The current research proposal therefore aims to examine the relation between a
range of psychological risk factors and several mental stress-induced
physiological responses in a large sample of PCI patients.
Study design
Prospective experimental study in which patients will be asked to fill out a
questionnaire, and to participate in the Trier Social Stress Test, including a
public speech task and a mental arithmetic task, while their physiological
response to this stressor is assessed.
Study burden and risks
The risk associated with the current study is low. For this mechanistic study,
investigators will ask patients to fill out a psychological survey, including
among others questions on personality, mood, anxiety, mindfulness, illness
perception, work stress, and satisfaction with life. Also, participation in a
mental stress test is requested, during which participants are subjected to
mild psychological stress.
Warandelaan 2
Tilburg 5037AB
NL
Warandelaan 2
Tilburg 5037AB
NL
Listed location countries
Age
Inclusion criteria
Elective percutaneous coronary intervention 3-4 months ago, stable, without complaints related to this PCI, or acute percutaneous coronary intervention 6 months ago, stable, without complaints related to this PCI;Not on beta-blocker medication or willing to discontinue beta-blocker medication for 48 hours preceding the stress test (when agreed upon by treating intervention cardiologist);Aged >=18;Fluent in Dutch
Exclusion criteria
Life threatening comorbidity (e.g. cancer) or psychiatric disorder (except mood disorders)
Unstable at 3 months post-elective PCI, with complaints, or unstable at 6 months post- acute PCI, with complaints.
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 | NL46111.028.13 |