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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307214
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Professor Augusto Gallino, Ospedale San Giovanni Bellinzona

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Syndrome X Takotsubo Cardiomyopathy Other: BaroReflex Sensitivity, endothelial function measurement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology of Two Orphan Cardiac Diseases
Study Start Date : October 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Coronary X syndrome
BaroReflex Sensitivity, endothelial function measurement
Other: BaroReflex Sensitivity, endothelial function measurement
no other
Other Names:
  • BaroReflex Sensitivity measurement by volume-clamp method (Finapress)
  • Endothelial function measured by Endopat

Tako-tsubo cardiomyopathy
BaroReflex Sensitivity, endothelial function measurement
Other: BaroReflex Sensitivity, endothelial function measurement
no other
Other Names:
  • BaroReflex Sensitivity measurement by volume-clamp method (Finapress)
  • Endothelial function measured by Endopat

Healty Volunteers
BaroReflex Sensitivity, endothelial function measurement
Other: BaroReflex Sensitivity, endothelial function measurement
no other
Other Names:
  • BaroReflex Sensitivity measurement by volume-clamp method (Finapress)
  • Endothelial function measured by Endopat




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307214


Locations
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Switzerland
Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
Bellinzona, Canton Ticino, Switzerland, 6500
Sponsors and Collaborators
Ospedale San Giovanni Bellinzona
Investigators
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Principal Investigator: Augusto Gallino, Prof MD Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
Study Chair: Mattia Cattaneo, MD Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
Study Chair: Alessandra Pia Porretta, MD Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
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Responsible Party: Professor Augusto Gallino, Professor MD, Ospedale San Giovanni Bellinzona
ClinicalTrials.gov Identifier: NCT02307214    
Other Study ID Numbers: CE 2688
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Cardiomyopathies
Microvascular Angina
Takotsubo Cardiomyopathy
Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Myocardial Ischemia
Vascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction