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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Ospedale San Giovanni Bellinzona

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • 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)
  • Endothelial dysfunction (Changes in Endopat score) [ Time Frame: Baseline ]
    Changes in Endopat score from baseline in three three groups (CSX, TTC, healty volunteers)


Original Secondary Outcome: Same as current

Information By: Ospedale San Giovanni Bellinzona

Dates:
Date Received: November 26, 2014
Date Started: October 2013
Date Completion:
Last Updated: April 25, 2016
Last Verified: April 2016