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

2026年5月17日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

40

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Ljubljana
      • Ljubljana、Ljubljana、スロベニア、1000
        • 募集
        • Advanced Heart Failure and Transplantation Program, Department of Cardiology, UMC Ljubljana, Slovenia
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

確率サンプル

調査対象母集団

Adult patients, predominantly females, with cardiovascular risk factors.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Recovery of left ventricular systolic function assessed by change in left ventricular ejection fraction (LVEF)
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Improvement in myocardial contractility and deformation assesed by change in left ventricular global longitudinal strain (LV GLS)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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.

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一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年9月6日

一次修了 (推定)

2026年6月30日

研究の完了 (推定)

2026年12月31日

試験登録日

最初に提出

2026年5月17日

QC基準を満たした最初の提出物

2026年5月17日

最初の投稿 (実際)

2026年5月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月22日

QC基準を満たした最後の更新が送信されました

2026年5月17日

最終確認日

2026年5月1日

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