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

Not Applicable

Completed

• Conditions: Syndrome X; Takotsubo Cardiomyopathy
• Interventions: Other: BaroReflex Sensitivity, endothelial function measurement

• Registration Number: NCT02307214
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-04
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tako-tsubo cardiomyopathy	BaroReflex Sensitivity, endothelial function measurement	BaroReflex Sensitivity, endothelial function measurement
Healty Volunteers	BaroReflex Sensitivity, endothelial function measurement	BaroReflex Sensitivity, endothelial function measurement
Coronary X syndrome	BaroReflex Sensitivity, endothelial function measurement	BaroReflex Sensitivity, endothelial function measurement

Primary Outcome Measures

Name	Time	Method
Difference in endothelial function in response to autonomic tone (Endopat score)	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

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

Trial Locations

Locations (1)

Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona; 🇨🇭 Bellinzona, Canton Ticino, Switzerland