The Heart Inside Out: emotions and mood as mediators of cardiac symptoms in microvascular dysfunction*

The Heart Inside Out: emotions and mood as mediators of cardiac symptoms in microvascular dysfunction* - The heart inside out.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43239

Enrollment

400

Registered

2016-06-08

Start date

2017-01-17

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Coronary microvascular disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: age

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results