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

17 maggio 2026 aggiornato da: Gregor Poglajen, University Medical Centre Ljubljana

Effects of CD34+ Stem Cells on Left Ventricular Dysfunction Among Patients With Takotsubo Syndrome

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.

Panoramica dello studio

Descrizione dettagliata

Takotsubo syndrome presents with a transient non-ischemic acute heart failure and relatively fast recovery of myocardial contractility. This medical condition is often precipitated by a previous trigger, such as physical or emotional stress. However, in approximately one-third of Takotsubo patients, the trigger remains unidentified. In terms of acute clinical presentation, Takotsubo patients with and without acute coronary syndrome-related symptoms have been recognized. Early recognition of the latter group is challenging due to the lack of clear indication for transthoracic echocardiography and coronary angiography with left ventriculography in this patient cohort, representing the gold standard in diagnostics of Takotsubo patients. Therefore, the prevalence of Takotsubo patients without acute coronary syndrome-related symptoms appears to be underestimated. In addition, novel data reveal that both short- and long-term prognoses in Takotsubo patients are comparable to the prognosis in acute coronary syndrome patients. Furthermore, chronic heart failure has been recognized in a subgroup of Takotsubo patients. To sum up, Takotsubo syndrome represents a heterogeneous medical condition, with a potential for adverse outcomes. This calls for new approaches to the diagnostics and treatment of this patient population.

Coronary microvascular dysfunction has been proposed as a crucial pathophysiological mechanism underlying Takotsubo pathogenesis, including the left ventricular dysfunction at acute episode and the degree/rate of left ventricular contractility improvement. As CD34+ cells are essential to coronary microvascular homeostasis we speculated on potential association between CD34+ cell count and changes in left ventricular function in patients with Takotsubo cardiomyopathy at baseline and 6-month follow-up.

In this single-center prospective pilot cohort study we included 34 consecutive patients with Takotsubo cardiomyopathy treated at our center between September 2021 and January 2026. Patients with a history of malignancy and concurrent acute coronary syndrome-mimicking conditions (myocardial infarction, myocarditis, etc) were not considered for this analysis. Takotsubo cardiomyopathy diagnosis was established per InterTac Registry criteria. Patients were enrolled within 24h of admission and underwent comprehensive clinical examination, blood biochemical and hematological analysis, and echocardiography at baseline and 6-month follow-up. Additionally, we expect at least half of the enrolled patients to complete cardiac MRI scan at baseline and 6-month follow-up. CD34+ cell count was measured using Beckman-Coulter Navios EX flow cytometry with standard antibodies according to ISAGE protocol.

The study results might enhance undertsanding of the pathophgysiological mechanism underlying structural and functional myocardial recovery among Takotsubo patients. Also, the study outcomes might provide crucial context for justifying further research work on investigating potential therapeutic effects of CD34+ cells on myocardial contractility recovery among Takotsubo patients.

Tipo di studio

Osservativo

Iscrizione (Stimato)

40

Contatti e Sedi

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Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Ljubljana
      • Ljubljana, Ljubljana, Slovenia, 1000
        • Reclutamento
        • Advanced Heart Failure and Transplantation Program, Department of Cardiology, UMC Ljubljana, Slovenia
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Adult patients, predominantly females, with cardiovascular risk factors.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Takotsubo patients with preserved OR mildly reduced/reduced LVEF at acute event.
Takotsubo patients divided in subgroups based on preserved or mildly reduced/reduced LVEF at acute event.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recovery of left ventricular systolic function assessed by change in left ventricular ejection fraction (LVEF)
Lasso di tempo: From enrollment to the end of observational period at 6-month follow-up.
Change in LVEF (%), measured by transthoracic echocardiography using Biplane Simpson's method.
From enrollment to the end of observational period at 6-month follow-up.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Improvement in myocardial contractility and deformation assesed by change in left ventricular global longitudinal strain (LV GLS)
Lasso di tempo: From enrollment to the end of observational period at 6-month follow-up.
Change in LV GLS (%), measured by transthoracic echocardiography using speckle-tracking method.
From enrollment to the end of observational period at 6-month follow-up.
Reduction in left ventricular filling pressure assessed by change in early mitral inflow velocity (E-wave) and the average of the septal and lateral early diastolic mitral annular velocities ratio (E/e' average)
Lasso di tempo: From enrollment to the end of observational period at 6-month follow-up.
Change in E/e' average, calculated from transthoracic echocardiography by dividing the peak early mitral inflow velocity (E-wave) by the average of the septal and lateral early diastolic mitral annular velocities (e') obtained via tissue doppler imaging.
From enrollment to the end of observational period at 6-month follow-up.
Recovery of impaired myocardial relaxation assessed by change in peak early mitral inflow velocity and peak atrial contraction wave velocity ratio (E/A ratio)
Lasso di tempo: From enrollment to the end of observational period at 6-month follow-up.
Change in E/A ratio, calculated from transthoracic echocardiography by dividing the peak early mitral inflow velocity (E-wave) by the peak atrial contraction velocity (A-wave), both measured via pulsed-wave Doppler in the apical four-chamber view.
From enrollment to the end of observational period at 6-month follow-up.
Reduction in pulmonary artery systolic pressure assessed by change in tricuspid regurgitation maximum gradient (TR max gradient)
Lasso di tempo: From enrollment to the end of observational period at 6-month follow-up.
Change in TR max gradient (mmHg), measured using transthoracic echocardiography by applying continuous wave (CW) doppler to the TR jet to determine the peak velocity, then applying the modified Bernoulli equation.
From enrollment to the end of observational period at 6-month follow-up.
Reduction in left ventricular size assessed by left ventricular end-diastolic volume index (LVEDVi)
Lasso di tempo: From enrollment to the end of observational period at 6-month follow-up.
Change in LVEDVi (mL/m2), calculated from transthoracic echocardiography using Biplane Simpson's method and indexed to body surface area.
From enrollment to the end of observational period at 6-month follow-up.
Reduction in left ventricular wall thickness assessed by posterior (inferolateral) wall diameter (PWd) and interventricular septal diameter (IVSd)
Lasso di tempo: From enrollment to the end of observational period at 6-month follow-up.
Change in PWd (mm) and IVSd (mm), assessed by transthoracic echocardiography using parasternal long-axis view.
From enrollment to the end of observational period at 6-month follow-up.
Improvement in right ventricular systolic function assessed by tricuspid annular plane systolic excursion (TAPSE)
Lasso di tempo: From enrollment to the end of observational period at 6-month follow-up.
Change in TAPSE (mm), assessed by transthoracic echocardiography and measured in the apical 4-chamber view using M-mode placed at the lateral tricuspid annulus.
From enrollment to the end of observational period at 6-month follow-up.
Reduction in the extent of myocardial oedema assessed by cardiac magnetic resonance imaging
Lasso di tempo: Baseline and 6-month follow-up.
Change in the extent of myocardial oedema, assessed by cardiac magnetic resonance imaging scan using T2-weighted imaging and T2-mapping (T2 relaxation times in miliseconds).
Baseline and 6-month follow-up.
Remnants of cardiac fibrosis assessed by the extent of late gadolinium enhancement (LGE)
Lasso di tempo: Baseline, 6-month follow-up.
Change in the extent of myocardial LGE (% of left ventricular mass), quantified by cardiac magnetic resonance (CMR).
Baseline, 6-month follow-up.
Recovery of coronary microvascular dysfunction assessed by change in angiogenesis-related biomarkers
Lasso di tempo: From enrollment to the end of observational period at 6-month follow-up.
Change in angiogenesis-related biomarker panel composite score, measured using a Luminex multiplex immunoassay.
From enrollment to the end of observational period at 6-month follow-up.
Reduction in cardiac congestion assessed by change in serum levels of natriuretic peptides (NT-proBNP)
Lasso di tempo: From enrollment to the end of observational period at 6-month follow-up.
Change in serum levels of NT-proBNP (ng/L), measured in blood sample by serum biochemical analysis.
From enrollment to the end of observational period at 6-month follow-up.

Collaboratori e investigatori

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Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 settembre 2021

Completamento primario (Stimato)

30 giugno 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

17 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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