NCT04178434 Internet-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries
| NCT ID | NCT04178434 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Per Tornvall |
| Condition | Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2021-11-11 |
| Primary Completion | 2024-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2021-11-11 with a primary completion date of 2024-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * a suspected diagnosis of MINOCA or takotsubo syndrome with coronary angiography without diameter stenosis ≥50% * 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: * strong clinical suspicion of myocarditis * spontaneous coronary artery dissection * acute pulmonary embolism * acute myocardial infarction type 2 * cardiomyopathy other than takotsubo syndrome * a previous myocardial infarction due to CAD * expected poor compliance to behavioural therapy * not likely to survive \> one year due to for example cancer
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04178434 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 79 Years, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04178434 currently recruiting?
Yes, NCT04178434 is actively recruiting participants. Contact the research team at per.tornvall@ki.se for enrollment information.
Where is the NCT04178434 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT04178434 clinical trial?
NCT04178434 is sponsored by Per Tornvall. The trial plans to enroll 64 participants.