Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02307214
Other study ID # CE 2688
Secondary ID
Status Completed
Phase N/A
First received November 26, 2014
Last updated April 25, 2016
Start date October 2013
Est. completion date April 2016

Study information

Verified date April 2016
Source Ospedale San Giovanni Bellinzona
Contact n/a
Is FDA regulated No
Health authority Switzerland: Cantonal Office of Public Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

Other:
BaroReflex Sensitivity, endothelial function measurement
no other

Locations

Country Name City State
Switzerland Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona Bellinzona Canton Ticino

Sponsors (1)

Lead Sponsor Collaborator
Ospedale San Giovanni Bellinzona

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress) Changes in BaroReflex Sensitivity from baseline in three three groups (CSX, TTC, healty volunteers) Baseline No
Secondary 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 No
Secondary Endothelial dysfunction (Changes in Endopat score) Changes in Endopat score from baseline in three three groups (CSX, TTC, healty volunteers) Baseline No
See also
  Status Clinical Trial Phase
Recruiting NCT04325321 - The Broken Heart Study II (BHS-II) N/A
Recruiting NCT03663348 - Registry of Patients With Takotsubo Syndrome
Recruiting NCT04695587 - The Role of Sympathetic Tone Regarding the Anatomical and Functional Recovery of the Left Ventricle in TakoTsubo Syndrome
Completed NCT05530135 - Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy N/A
Not yet recruiting NCT05946772 - Cyclosporine In Takotsubo Syndrome Phase 2
Completed NCT02240056 - Brain fMRT In Takotsubo Cardiomyopathy
Recruiting NCT05977049 - Psychosocial Support for Patients With Takotsubo Syndrome N/A
Recruiting NCT06277297 - Prognotic Role of CMR in Takotsubo Syndrome
Completed NCT03787810 - Left Ventricular Dysfunction in Critically Ill Patients
Active, not recruiting NCT00123695 - Serial Echocardiography After Subarachnoid Hemorrhage N/A
Recruiting NCT05793008 - Characterization of priMary And sEcondary STress Related takOtsubo N/A
Recruiting NCT04513054 - Is There a Genetic Predisposition for Acute Stress-induced (Takotsubo) Cardiomyopathy N/A
Completed NCT04425785 - Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study N/A
Recruiting NCT02361073 - The Role of Emotional Stress in Patients With Stress-induced Cardiomyopathy N/A
Recruiting NCT06323811 - Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics N/A
Recruiting NCT03299569 - Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland
Recruiting NCT01947621 - International Takotsubo Registry (InterTAK Registry) N/A
Completed NCT04684004 - Hyperglycemia in Patients With Takotsubo Syndrome
Completed NCT02759341 - Brain-heart Interactions in Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: N/A
Completed NCT02659878 - Takotsubo Cardiomyopathy in Patients Suffering From Acute Non-traumatic Subarachnoid Hemorrhage