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NCT Number: NCT02307214

Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology

Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and chronic cardiac conditions whose clinical presentation, mimicking the onset of acute myocardial ischemia in absence of epicardial coronary disease, has progressively gained the interest of the scientific community. However, despite significant progress, their underlying pathophysiology, which seems to evoke some similarities, still remains elusive. Endothelial dysfunction and autonomic imbalance have both been individually implied in their puzzling pathogenesis.

The investigators plan to conduct our study in a cohort of TTC patients, CSX patients and healthy volunteers with the following primary objective: to assess the response of endothelial function (through the Endopat score) to the autonomic tone activation induced by a 10-minute stress mental test. The assessment of autonomic tone during activation through the evaluation of Spontaneous BaRoreflex Sensitivity (BRS) and its correlation with endothelial function (Endopat score) will represent secondary objectives.

Our study will enroll 15 patients with TTC at least six months after the event, 15 patients with classic CSX and 15 healthy volunteers who will serve as control.

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Key information

Conditions

Syndrome X Angina Pectoris Cardiomyopathies Cardiovascular Diseases Heart Diseases Microvascular Angina Myocardial Ischemia Takotsubo Cardiomyopathy Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona

Bellinzona, Canton Ticino, 6500, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with the Mayo Clinic's criteria established diagnosis of TTC at least 6 month after the acute event
  • Patients with CSX defined by the presence of anginal pain, positive exercise stress testing and negative coronary angiography.
  • A comparable cohort of healthy volunteers age and sex-matched with patients

Exclusion criteria

  • Short-term life-threatening pathology (life expectancy < 6 months)
  • Physically unable to participate in the study
  • Compliance not guaranteed
  • Pregnancy
  • Conditions that make BRS and Endopat measurements impossible

Treatment and study plan

BaroReflex Sensitivity, endothelial function measurement

Other

no other

Other names: BaroReflex Sensitivity measurement by volume-clamp method (Finapress), Endothelial function measured by Endopat

Primary outcomes

  1. Difference in endothelial function in response to autonomic tone (Endopat score)

    Time frame: Baseline

    Difference in endothelial function assessed by Endopat score in response to autonomic tone induced by 10-minute mental stress test between the three groups (CSX, TTC, healty volunteers)

Secondary outcomes

  1. BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress)

    Time frame: Baseline

    Changes in BaroReflex Sensitivity from baseline in three three groups (CSX, TTC, healty volunteers)

  2. BaroReflex Sensitivity and endothelial dysfunction (

    Time frame: Baseline

    Correlation with between BaroReflex Sensitivity [volume clamp method] and EndoPAT score in the three groups (CSX, TTC, healty volunteers)

  3. Endothelial dysfunction (Changes in Endopat score)

    Time frame: Baseline

    Changes in Endopat score from baseline in three three groups (CSX, TTC, healty volunteers)

Sponsors and collaborators

Lead sponsor

Ospedale San Giovanni Bellinzona

Other

Registry information

Official study title

Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology of Two Orphan Cardiac Diseases

Acronym: ENDAUT

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2014
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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