Anxiety, Stress and Pain & Myocardial Infarction

Sponsor

Medical University of Graz (Other)

Overall Status

Recruiting

CT.gov ID

NCT04130269

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 7, 2020

Anticipated Primary Completion Date :

Oct 7, 2022

Anticipated Study Completion Date :

Oct 7, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Patients with MCI

Patients with myocardial infarction (STEMI/NSTEMI) aged 19-90

Other: No intervention

Questionnaires, lab-run

Outcome Measures

Primary Outcome Measures

PTSD [6 months]
Number of patients who develop PTSD

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz	Styria	Austria	8036

Sponsors and Collaborators

Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT04130269

Other Study ID Numbers:

7479
31-478 ex 18/19

First Posted:

Oct 17, 2019

Last Update Posted:

Sep 23, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocardial Infarction

Infarction

Study Results

No Results Posted as of Sep 23, 2021