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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 (PTSDami)

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ClinicalTrials.gov Identifier: NCT04130269
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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 oder the syndrom of PTSD after an acute myocardial infarction.

Condition or disease Intervention/treatment
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 oder the syndrom of 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 (troponines), 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.


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Study Type : Observational
Estimated 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
Estimated Study Start Date : October 7, 2019
Estimated Primary Completion Date : October 7, 2020
Estimated Study Completion Date : October 7, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. PTSD [ Time Frame: 6 months ]
    Number of patients who develop PTSD



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Men and women 19-90.
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 fullfilment of inclusion criteria
  • non-compliant patients (dementia, delirium)
  • steroidtherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130269


Locations
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Austria
Medical University of Graz Not yet recruiting
Graz, Styria, Austria, 8036
Contact: Andreas Baranyi, Prof. MD    +4331638586241    an.baranyi@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz

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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT04130269     History of Changes
Other Study ID Numbers: 7479
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Ischemia
Myocardial Infarction
Infarction
Stress Disorders, Post-Traumatic
Mental Disorders
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders