Anxiety, Stress and Pain & Myocardial Infarction

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04130269
• Other study ID #: 7479
• Secondary ID: 31-478 ex 18/19
• Status: Recruiting
• Start date: April 7, 2020
• Est. completion date: December 7, 2024

Study information

• Verified date: January 2023
• Source: Medical University of Graz
• Contact: Andreas Baranyi, MD
• Phone: 004331638513612
• Email: an.baranyi[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 7, 2024
• Est. primary completion date: December 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• No intervention
Questionnaires, lab-run

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD	Number of patients who develop PTSD	6 months