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

NCT02307214 | Completed DMC

• 1 other identifier: CE 2688
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Syndrome X; Takotsubo Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress)

  Baseline

• BaroReflex Sensitivity and endothelial dysfunction (

  Baseline

• Endothelial dysfunction (Changes in Endopat score)

  Baseline

Study Arms (3)

Coronary X syndrome

OTHER

BaroReflex Sensitivity, endothelial function measurement

Other: BaroReflex Sensitivity, endothelial function measurement

Tako-tsubo cardiomyopathy

OTHER

BaroReflex Sensitivity, endothelial function measurement

Other: BaroReflex Sensitivity, endothelial function measurement

Healty Volunteers

OTHER

BaroReflex Sensitivity, endothelial function measurement

Other: BaroReflex Sensitivity, endothelial function measurement

Interventions

BaroReflex Sensitivity, endothelial function measurement OTHER

no other

Also known as: BaroReflex Sensitivity measurement by volume-clamp method (Finapress), Endothelial function measured by Endopat

Coronary X syndrome; Healty Volunteers; Tako-tsubo cardiomyopathy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale San Giovanni Bellinzona: lead

Study Sites (1)

Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona

Bellinzona, Canton Ticino, 6500, Switzerland

Location

MeSH Terms

Conditions

Microvascular Angina; Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cardiomyopathies; Ventricular Dysfunction, Left; Ventricular Dysfunction

Study Officials

• Augusto Gallino, Prof MD

  Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 4, 2014
• Study Start: October 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

CH (1)