RecruitingNot Applicable

The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome

Slovenia40 participantsStarted 2021-09-06

Plain-language summary

The underlying mechanisms of microvascular dysfunction in Takotsubo cardiomyopathy remain incompletely understood. As CD34+ cells are essential to coronary microvascular homeostasis we will investigate the potential association between CD34+ cell count and changes in left ventricular function in patients with Takotsubo cardiomyopathy at baseline and 6-month follow-up.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Minimum age 18 years * Established TTS per InterTak registry criteria * Signed consent form Exclusion Criteria: * Patients under the age of 18 years * Ischemic heart disease with at least one complete total occlusion * Other concurrent cardiomyopathies * Active infectious myocarditis * obstructive coronary artery disease * Previous hospital stay due to acute coronary syndrome (myocardial infarction) in the last 6 months before TTS acute event * Previous interventional coronary artery procedure in the last 6 months before TTS acute event * Significant valvular heart disease * Significant peripheral artery occlusive disease * Active or remitted hematologic malignancy * Patients receiving immunosuppressive therapy * Significant comorbiditeis affecting patients survival (malignancy) * Failure to obtain freely given, informed consent form.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recovery of left ventricular systolic function assessed by change in left ventricular ejection fraction (LVEF)

Timeframe: From enrollment to the end of observational period at 6-month follow-up.

Trial details

NCT IDNCT07604467

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

Contact for this trial

Mark Jovanović, MD

+38640977307 mark.jovanovic@kclj.si

View on ClinicalTrials.gov More Tako Tsubo Cardiomyopathy trials