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

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

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.

Study Overview

• Status: Completed
• Conditions: Takotsubo Cardiomyopathy; Syndrome X
• Intervention / Treatment: Other: BaroReflex Sensitivity, endothelial function measurement

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton Ticino
    • Bellinzona, Canton Ticino, Switzerland, 6500
      • Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in endothelial function in response to autonomic tone (Endopat score)	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)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress)	Changes in BaroReflex Sensitivity from baseline in three three groups (CSX, TTC, healty volunteers)	Baseline
BaroReflex Sensitivity and endothelial dysfunction (	Correlation with between BaroReflex Sensitivity [volume clamp method] and EndoPAT score in the three groups (CSX, TTC, healty volunteers)	Baseline
Endothelial dysfunction (Changes in Endopat score)	Changes in Endopat score from baseline in three three groups (CSX, TTC, healty volunteers)	Baseline

Collaborators and Investigators

• Sponsor: Ospedale San Giovanni Bellinzona
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 26, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Angina Pectoris; Ventricular Dysfunction, Left; Ventricular Dysfunction; Syndrome; Cardiomyopathies; Microvascular Angina; Takotsubo Cardiomyopathy
• Other Study ID Numbers: CE 2688