Clinical trial NCT04130269: Anxiety, Stress and Pain & Myocardial Infarction
Official title: The Impact of Anxiety, Stress and Pain in the Early Phase of Myocardial Infarction on the Development of Anxiety Symptoms and Posttraumatic Stress Disorder in the Long Term Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women 19-90.

Brief summary: People often experience the acute phase of a myocardial infarction as a stressful and traumatic event that seems lifethreatening. Such anxiety, pain and stress can lead to the development of posttraumatic stress disorder in the long run. Previous studies suggest that there might be a relevant percentage of people developing Posttraumatic Stress Disorder (PTSD) after a myocardial infarction. Posttraumatic stress disorder is a risk factor for the development of coronary heart disease. The goal of this study is to detect the percentage of people that develop symptoms of anxiety, stress, and PTSD after an acute myocardial infarction.

Detailed description: People often experience the acute phase of a myocardial infarction as a stressful and traumatic event that seems lifethreatening. Such anxiety, pain and stress can lead to the development of posttraumatic stress disorder in the long run. Previous studies suggest that there might be a relevant percentage of people developing PTSD after a myocardial infarction. Posttraumatic stress disorder is a risk factor for the development of coronary heart disease. The goal of this study is to detect the percentage of people that develop symptoms of anxiety, stress and PTSD after an acute myocardial infarction.

Patients will be examined during three times - in the acute myocardial infarction period (Day 1-3), before dismissal (Day 5-14) and after 6 months for a follow-up. During all times they will be given questionnaires asking about their levels of stress, anxiety and general well-being as well as tests checking their cognitive abilities (thus to find out if they decrease over time). Moreover, blood samples checking cortisol levels as well as metanephrine levels will be taken in order to objectify the levels of stress that are stated by the patients. Furthermore, clinical evaluations, laboratory runs (troponin), ECGs and echocardiographies will be done at all three points in time.

The goal is to detect the biopsychosocial relations and to develop better prevention.

Eligibility criteria: Inclusion Criteria:

* willingness to participate in the study
* men and women 19-90
* after myocardial infarctions
* no psychiatric disease before myocardial infarction
* no other severe disease influencing the immune system

Exclusion Criteria:

* non fulfilment of inclusion criteria
* non-compliant patients (dementia, delirium)
* steroid-therapy

Primary outcomes:
measure: PTSD
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References: