Optimized Characterization of Takotsubo Syndrome by Obtaining Pressure Volume Loops

NCT ID: NCT03726528

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2022-10-07

Brief Summary

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Aim of this prospective study is to assess the pathophysiology of Takotsubo Syndrome by obtaining pressure volume loops with conductance catheters, which allows detailed conclusions regarding systolic and diastolic hemondynamics and subsequently regarding potential underlying mechanisms

Detailed Description

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Conditions

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Takotsubo Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental intervention

Group Type EXPERIMENTAL

Measurements of left ventricular pressure and volume

Intervention Type DIAGNOSTIC_TEST

Patients with suspected Takotsubo syndrome (typical ballooning in left ventriculography without significant obstructive coronary artery disease that sufficiently explains the contraction abnormalities) will undergo continuous online measurements of left ventricular pressure and volume using conductance catheters. Cardiac magnetic resonance (CMR) imaging will be performed in patients without contraindications for optimized morphological characterization and exclusion of important differential diagnoses.

Interventions

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Measurements of left ventricular pressure and volume

Patients with suspected Takotsubo syndrome (typical ballooning in left ventriculography without significant obstructive coronary artery disease that sufficiently explains the contraction abnormalities) will undergo continuous online measurements of left ventricular pressure and volume using conductance catheters. Cardiac magnetic resonance (CMR) imaging will be performed in patients without contraindications for optimized morphological characterization and exclusion of important differential diagnoses.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Confirmed Takotsubo syndrome according to current diagnostic criteria including complete normalization of left ventricular function during follow-up
* Sinus rhythm during invasive measurements
* Age ≥18 years
* Written informed consent

Exclusion Criteria

* Cardiogenic shock
* Signs of myocarditis or myocardial infarction with spontaneous lysis of thrombus in cardiac magnetic resonance imaging
* Pregnancy
* Participation in another trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Ingo Eitel

MD, Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical clinic II-UKSH

Lübeck, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

References

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Stiermaier T, Reil JC, Sequeira V, Rawish E, Mezger M, Patz T, Paitazoglou C, Schmidt T, Frerker C, Steendijk P, Reil GH, Eitel I. Hemodynamic Assessment in Takotsubo Syndrome. J Am Coll Cardiol. 2023 May 23;81(20):1979-1991. doi: 10.1016/j.jacc.2023.03.398.

Reference Type DERIVED
PMID: 37197841 (View on PubMed)

Other Identifiers

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17-078

Identifier Type: -

Identifier Source: org_study_id

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