Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Internat-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries (e-SMINC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178434
Recruitment Status : Not yet recruiting
First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Collaborators:
UPPSALA UNIVERSITET
Mid Sweden University
Information provided by (Responsible Party):
Per Tornvall, Karolinska Institutet

Brief Summary:
Patient with myocardial infarction with non-obstructive coronary arteries and takotsubo syndrome often have high levels of stress and anxiety. At present there are no treatment alternatives in this group of patients. Previously, cognitive behavioral therapy (CBT), primarily aiming at relieving stress, has been shown to decrease morbidity in patient with myocardial infarction with obstructive coronary arteries. The present open randomized study aims to decrease stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries and takotsubo syndrome by an internet-based (CBT) focusing on stress and anxiety.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Behavioral: Internet-based CBT intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: E-health Treatment in Stockholm Myocardial Infarction With None-obstructive Coronaries Study
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Internet-based CBT intervention
A nine step internet-based intervention with focus on stress and cardiac anxiety
Behavioral: Internet-based CBT intervention
A nine step intervention including internet-based feedback by psychologists

No Intervention: Treatment as usual
Regular follow-up with two doctor and one nurse appointment



Primary Outcome Measures :
  1. Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14) [ Time Frame: 4 months after the acute event ]
    Normalisation of PSS-14 (<25 on a scale 0-56 with high numbers indicating increased stress)

  2. Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 4 months after the acute event ]
    Normalisation of HADS-A (<8 on a scale 0-21 with high numbers indicating increased anxiety)


Secondary Outcome Measures :
  1. Self-rated stress as determined by Perceived Stress Scale 14 (PSS-14) [ Time Frame: 12 months after the acute event ]
    Normalisation of PSS-14 (<25 on a scale 0-56 with high numbers indicating increased stress)

  2. Self-rated anxiety as determined by Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 months after the acute event ]
    Normalisation of HADS-A (<8 on a scale 0-21 with high numbers indicating increased anxiety)

  3. Self-rated quality-of-life determined by Research ANd Development-36 (RAND-36) [ Time Frame: 4 and 12 months after the acute event ]
    RAND-36: 0-100 with high numbers indicating better quality-of-life

  4. Self-rated cardiac anxiety determined by Cardiac Anxiety Questionnaire (CAQ) [ Time Frame: 4 and 12 months after the acute event ]
    CAQ: 0-72 with high numbers indicating increased cardiac anxiety

  5. Self-rated post-traumatic symptoms determined by Impact of Event Scale-6 (IES-6) [ Time Frame: 4 and 12 months after the acute event ]
    IES-6: 0-30 with high numbers indicating increased post-traumatic symptoms

  6. Sick leave [ Time Frame: 12 months after the acute event ]
    Total number of days

  7. Health-care visits [ Time Frame: 12 months after the acute event ]
    Total number of visits

  8. Cortisol in hair [ Time Frame: 4 and 12 months after the acute event ]
    Hair cortisol will be determined by RIA-technique in pg/mg

  9. Physiological recovery after stress determined by Heart Rate Variability (HRV) [ Time Frame: 4 months after the acute event ]
    HRV will be measured by time and frequency domains and by non-linear methods

  10. Physiological recovery after stress determined by salivary cortisol [ Time Frame: 4 months after the acute event ]
    Salivary cortisol will be determined by RIA-technique in pg/mg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a final diagnosis of MINOCA or takotsubo syndrome with coronary angiography without stenosis > 50% within one month of the acute event
  • age 35-80 years
  • admission-ECG with sinus rhythm
  • PSS-14 ≥ 25 and/or HADS-A ≥ 8 during admission
  • reading and writing proficiency in Swedish
  • computer/Internet access and literacy

Exclusion Criteria:

  • acute myocarditis according to CMR imaging, of note is that the patient can be excluded after primary inclusion but before randomisation due to a late CMR investigation
  • acute pulmonary embolism
  • acute myocardial infarction type 2
  • severe chronic obstructive pulmonary disease stage ≥ GOLD 3 (i.e. FEV1 < 50% predicted and ≥ 2 exacerbations per year, or one or more requiring hospitalisation)
  • severe kidney disease defined as eGFR < 30 mL/min
  • cardiomyopathy other than takotsubo syndrome
  • a previous myocardial infarction due to CAD.
  Study Documents (Full-Text)

Documents provided by Per Tornvall, Karolinska Institutet:
Layout table for additonal information
Responsible Party: Per Tornvall, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04178434    
Other Study ID Numbers: 20191111
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Per Tornvall, Karolinska Institutet:
Myocardial infarction
Non-obstructive coronary arteries
Takotsubo syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases