We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

TAKO-TSUBO Cardiomyopathy and Genetic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01520610
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
Fédération Française de Cardiologie
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

This is a case-control association study with multicentric prospective recruitment.

Tako-TSUBO cardiomyopathy is a new clinical entity mimicking an acute coronary syndrome. It is characterized by reversible left ventricular dysfunction that is frequently precipitated by a stressful event and most of patients are postmenopausal women.

Several hypotheses concerning pathogenesis of Tako-TSUBO cardiomyopathy have been proposed, but at present, exaggerated sympathetic stimulation is the main hypothesis. However, the investigators don't know why some patients with stressful event may present Tako-TSUBO cardiomyopathy whereas most of them don't.

The investigators hypothesize that polymorphisms in the genes involved in the adrenergic pathway resulting in greater catecholamine sensitivity would be associated with an increased risk of Tako-TSUBO cardiomyopathy.


Condition or disease
Tako-TSUBO Cardiomyopathy Acute Coronary Syndrome

Detailed Description:

We hypothesize that polymorphisms in the genes involved in the adrenergic pathway resulting in greater catecholamine sensitivity would be associated with an increased risk of Tako-TSUBO cardiomyopathy.

Aim of this study:

Primary endpoint: Cognitive study aiming at identifying genetic polymorphisms in adrenergic pathway responsible for the Tako-TSUBO cardiomyopathy susceptibly.

Secondary endpoint: Study of clinical, ECG, angiographic, echocardiographic characteristics and outcome of patients presenting with Tako-TSUBO cardiomyopathy.

Methods:

Case-control association study with multicentric prospective recruitment. The study population will be consisted of 800 Caucasians subjects: 200 patients with Tako-TSUBO cardiomyopathy and an age- and sex-matched control group (n = 600) of 400 patients with acute coronary syndrome and 200 patients with stressful event (emergency postoperative patients) but without Tako-TSUBO cardiomyopathy. Sixteen candidates genes from the catecholamine pathway will be studied.

The diagnosis of Tako-TSUBO cardiomyopathy will be defined as (1) an acute chest pain during a stressful incident associated with ST-segment abnormalities and/or increased serum troponin level, (2) transient left ventricular systolic dysfunction, and (3) no coronary lesions related to the left ventricular dysfunction.

Diagnosis of acute coronary syndrome will be performed according to the definition of the American Heart Association/American College of Cardiology and European Society of Cardiology.

We will genotype all the known functional SNPs (Single Nucleotide Polymorphisms) and the Tag SNPs representative of at least 80% of the total genetic diversity (available at HapMap web site). SNPs will be studied alone or combined in haplotype.


Study Type : Observational
Actual Enrollment : 530 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic Polymorphisms in Catecholamine Pathway Responsible for the Tako-TSUBO Cardiomyopathy Susceptibly (TAKO-GENE)
Study Start Date : November 2011
Primary Completion Date : November 2014
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Group/Cohort
CTT
Patients with cardiopathy of tako TSUBO.
SCA
Patients with acute coronary syndrome but without Tako-TSUBO cardiomyopathy.
Surgical stress
patients with stressful event (emergency postoperative patients) but without Tako-TSUBO cardiomyopathy.



Primary Outcome Measures :
  1. DNA analysis [ Time Frame: 48 months ]
    To identify genetic polymorphisms in adrenergic pathway responsible for the Tako-TSUBO cardiomyopathy susceptibly


Secondary Outcome Measures :
  1. Diagnosis and prognosis of Tako-TSUBO cardiomyopathy [ Time Frame: 48 months ]
    To assess diagnostic criteria of Tako-TSUBO cardiomyopathy To assess the prognosis of Tako-TSUBO cardiomyopathy


Biospecimen Retention:   Samples With DNA
20 ml of blood sample will be collected from all patients enrolled in order to DNA analysis.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be consisted of 800 Caucasians subjects: 200 patients with Tako-Tsubo cardiomyopathy and an age- and sex-matched control group (n = 600) of 400 patients with acute coronary syndrome and 200 patients with stressful event (emergency postoperative patients) but without Tako-Tsubo cardiomyopathy.
Criteria

"Tako-TSUBO" group:

Inclusion criteria :

  • Patients presenting with Tako-TSUBO cardiomyopathy defined as: 1) an acute chest pain during a stressful incident associated with ST-segment abnormalities and/or increased serum troponin level, 2) transient left ventricular systolic dysfunction, and 3) no coronary lesions related to the left ventricular dysfunction
  • Age > 18
  • Written consent
  • Caucasian origin
  • Affiliation to health care system

Exclusion criteria :

  • Patients presenting with pheochromocytoma
  • Patients presenting with myocarditis
  • Patients presenting with subarachnoid hemorrhage

"Acute coronary syndrome" group (age- and sex-matched control group):

Inclusion criteria :

  • Patients presenting with an acute coronary syndrome (according to the definitions of guidelines)
  • Age > 18
  • written consent
  • Caucasian origin
  • Affiliation to health care system

Exclusion criteria :

  • Patients presenting with a suspicion of Tako-TSUBO cardiomyopathy
  • Patients presenting with a history of Tako-TSUBO cardiomyopathy

"Surgical stress" group (age- and sex-matched control group):

Inclusion criteria :

  • Patients hospitalized for an urgent surgery
  • Age > 18
  • Written consent
  • Caucasian origin
  • Affiliation to health care system

Exclusion criteria :

  • Patients presenting with increase of troponin after surgery
  • Patients presenting with ECG abnormalities after surgery
  • Patients presenting with a suspicion of Tako-TSUBO cardiomyopathy
  • Patients presenting with a history of Tako-TSUBO cardiomyopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520610


Locations
France
Name: Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines
Boulogne Billancourt, Hautes des Seine, France, 92210
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fédération Française de Cardiologie
Investigators
Principal Investigator: Nicolas Mansencal, MD, PHD Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01520610     History of Changes
Other Study ID Numbers: AOR 10018
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: February 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Tako-TSUBO Cardiomyopathy
Stress Cardiomyopathy
Myocardiopathies
Acute Coronary Syndrome
Gene

Additional relevant MeSH terms:
Acute Coronary Syndrome
Cardiomyopathies
Takotsubo Cardiomyopathy
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction