TAKO-TSUBO Cardiomyopathy and Genetic

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Fédération Française de Cardiologie
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01520610
First received: December 23, 2011
Last updated: September 16, 2014
Last verified: November 2013

December 23, 2011
September 16, 2014
November 2011
November 2014   (final data collection date for primary outcome measure)
DNA analysis [ Time Frame: 48 months ] [ Designated as safety issue: No ]
To identify genetic polymorphisms in adrenergic pathway responsible for the Tako-TSUBO cardiomyopathy susceptibly
Same as current
Complete list of historical versions of study NCT01520610 on ClinicalTrials.gov Archive Site
Diagnosis and prognosis of Tako-TSUBO cardiomyopathy [ Time Frame: 48 months ] [ Designated as safety issue: No ]
To assess diagnostic criteria of Tako-TSUBO cardiomyopathy To assess the prognosis of Tako-TSUBO cardiomyopathy
Same as current
Not Provided
Not Provided
 
TAKO-TSUBO Cardiomyopathy and Genetic
Genetic Polymorphisms in Catecholamine Pathway Responsible for the Tako-TSUBO Cardiomyopathy Susceptibly (TAKO-GENE)

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

20 ml of blood sample will be collected from all patients enrolled in order to DNA analysis.

Non-Probability Sample

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.

  • Tako-TSUBO Cardiomyopathy
  • Acute Coronary Syndrome
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
530
November 2015
November 2014   (final data collection date for primary outcome measure)

"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
Both
18 Years and older
No
Contact: Nicolas Mansencal, MD PHD +33 (0)1 49 09 56 31 nicolas.mansencal@apr.aphp.fr
France
 
NCT01520610
AOR 10018
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Fédération Française de Cardiologie
Principal Investigator: Nicolas Mansencal, MD, PHD Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines
Assistance Publique - Hôpitaux de Paris
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP