Primary objective 1: To determine whether expressed emotions, current mood and perceived stress are associated with the presence of cardiac symptoms in patients with coronary microvascular disease.Hypothesis: Expressed emotions, current mood, and…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
parameters primary research question 1:
Cardiac symptoms: Reported during stress MPI: chest pain, dyspnea or other
(e.g. flushing, nausea, pain in neck/jaw), and intensity of symptoms on a 0-10
VAS scale.
Groups: Three groups will be created, based on presence or absence of
myocardial ischemia as detected with the MPI, and presence or absence of
clinically significant CAD (at least one coronary lesion > 50%, or history of
PCI/CABG) based on hospital records:
(Suspect) Coronary microvascular disease (CMD) = presence of ischemia and
nonobstructive CAD
Reference group = absence of ischemia
CAD group = presence of ischemia and obstructive CAD.
Expressed emotions: Prevalence and intensity of 6 key emotions: happy, sad,
angry, surprised, scared, disgusted, or neutral as measured by recordings of
the face during rest and stress, and analysed using Noldus FaceReader software.
Mood and stress: Short form of the profile of mood states (POMS). Perceived
stress, and current emotions on a 0-10 VAS scale, as have been studied before.
Endpoint parameter primary research question 2:
Quality of life: Questionnaires on quality of life and health status will be
filled-out by the participants at 12 months.
Hospital records: At 12 months we aim to collect health care utilization from
hospital records at the Elisabeth-TweeSteden Hospital on: number and date of
(emergency dept) visits using invasive/noninvasive testing or procedures.
Secondary outcome
Hemodynamics: Heart rate, blood pressure and ECG at rest and stress are
recorded as part of the routine MPI procedure.
Distress and sociodemographic factors: Questions on sociodemographic variables,
and validated questionnaires on psychosocial factors will be filled out by the
participants.
Background summary
Patients with cardiac symptoms undergo testing to determine the presence or
absence of clinically significant CAD. In the Netherlands, over 54,000 coronary
angiographies are performed annually. An estimated 50-80% of women and 30-60%
of have nonobstructive CAD, and are being treated conservatively. However,
myocardial ischemia in the absence of clinically significant CAD is not without
cardiovascular risk. Our TweeSteden Mild Stenosis (TWIST) study, has also shown
that 44% of these patients continue to report chest pain 3 months later, and
chest pain is related to psychological distress and Type D personality.This
group is hypothesized to be at (increased) risk for poor quality of life,
recurrent diagnostic testing, hospitalization and long-term major adverse
cardiac events.
In the present study we look at the role of emotions and mood in cardiac
symptoms and myocardial ischemia .
Coronary Microvascular Dysfunction (CMD) is the presence of ischemia in the
absence of obstructive coronary artery disease. CMD is believed to be caused by
stenotic , or endothelial dysfunction of small coronary arteries. CMD can be
determined on the basis of a myocardial perfusion scan for the presence of
ischemia, and additional information about the presence or absence of
obstructive coronary artery disease.
It is necessary to investigate the role of psychological symptoms, in view of
the prevalence of anxiety associated with recurrent chest pain .
Previous studies have shown that acute mental stress is associated with
increased sympathetic activation and (nor)adrenaline release affecting
vasoconstriction. In line with this evidence studies have shown that mental
stress can induce myocardial ischemia. Moreover,emotions such as fear have
been associated with higher cardiovascular reactivity. Heart rate and blood
pressure provide additional cues on the activated or inhibitory pathway of
distress and fear, which are routinely being assessed during myocardial
perfusion imaging.
Study objective
Primary objective 1: To determine whether expressed emotions, current mood and
perceived stress are associated with the presence of cardiac symptoms in
patients with coronary microvascular disease.
Hypothesis: Expressed emotions, current mood, and perceived stress mediate the
association between CMD and cardiac symptoms.
Primary objective 2: To establish whether patients with CMD, compared to the
reference and CAD group, are significantly more likely to experience poor
quality of life and recurrent health care utilization at 12 months follow-up,
and whether is this association is affected by psychological distress.
Hypothesis: CMD is significantly associated with poor quality of life, cardiac
symptoms and recurrent health care utilization when compared to the reference
group, and CAD group. The presence of psychological distress as measured by
anxiety, depressive symptoms or Type D personality is expected to mediate this
association in each patient group.
Study design
Study design: Quasi experimental longitudinal design of three groups with
follow-up assessments of quality of life and health care utilization.
Study burden and risks
The proposed study incurs no extra risk to patients, as they receive no
additional treatment na/ or tests nor will any treatment be withheld from them
compared to patients who choose not to participate or are excluded on the basis
of the exclusion criteria. No extra venapuncture will take place.The only
burden to patients is the time that it will take to complete a set of
psychological questionnaires on site, which is estimated to take 1 hour.
Another set of questionnaires can be filled-out at home and returned by
pre-stamped envelope.
Warandelaan 2
Tilburg 5000LE
NL
Warandelaan 2
Tilburg 5000LE
NL
Listed location countries
Age
Inclusion criteria
All patients referred to the Verbeeten Institute Tillburg who are eligible for adenosine or exercise induced single-photon emission computed tomography rest-stress test (myocardial imaging), older than 18 years of age and capable of answering questionnaires.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study: age < 18 years, a life-threatening disease, and inability to fill out questionnaires.
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 | NL56707.028.16 |