Anxiety, Stress and Pain & Myocardial Infarction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Andreas Baranyi, MD; Phone Number: 004331638513612; Email: an.baranyi@medunigraz.at
• Study Contact Backup: Name: Hans-Bernd Rothenhäusler, MD; Phone Number: 004331638513612

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Medical University of Graz
      • Contact: Andreas Baranyi, Prof. MD; Phone Number: +4331638586241; Email: an.baranyi@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Men and women 19-90.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with MCI; Patients with myocardial infarction (STEMI/NSTEMI) aged 19-90	Other: No intervention; Questionnaires, lab-run

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD	Number of patients who develop PTSD	6 months

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Anticipated): December 7, 2024
• Study Completion (Anticipated): December 7, 2024

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 7479; 31-478 ex 18/19 (Other Identifier: Ethikkommission, Medical University of Graz)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No