Clinical trial NCT02307214: Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology
Official title: Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology of Two Orphan Cardiac Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syndrome X
Takotsubo Cardiomyopathy
Lead sponsor: Ospedale San Giovanni Bellinzona
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Difference in endothelial function in response to autonomic tone (Endopat score)
timeFrame: Baseline
Secondary outcomes:
measure: BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress)
timeFrame: Baseline
measure: BaroReflex Sensitivity and endothelial dysfunction (
timeFrame: Baseline
measure: Endothelial dysfunction (Changes in Endopat score)
timeFrame: Baseline
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
state: Canton Ticino
Study officials:
affiliation: Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
name: Augusto Gallino, Prof MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
name: Mattia Cattaneo, MD
role: STUDY_CHAIR
affiliation: Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
name: Alessandra Pia Porretta, MD
role: STUDY_CHAIR
References: