TAKO-TSUBO Cardiomyopathy and Genetic

NCT01520610 | Completed DMC

• 1 other identifier: AOR 10018
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

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.

Conditions

Tako-TSUBO Cardiomyopathy; Acute Coronary Syndrome

Keywords

Tako-TSUBO Cardiomyopathy; Stress Cardiomyopathy; Myocardiopathies; Acute Coronary Syndrome; Gene

Outcome Measures

Primary Outcomes (1)

• DNA analysis

  To identify genetic polymorphisms in adrenergic pathway responsible for the Tako-TSUBO cardiomyopathy susceptibly

  48 months

Secondary Outcomes (1)

• Diagnosis and prognosis of Tako-TSUBO cardiomyopathy

  48 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients presenting with pheochromocytoma
• Patients presenting with myocarditis
• Patients presenting with subarachnoid hemorrhage
• "Acute coronary syndrome" group (age- and sex-matched control group):
• Patients presenting with an acute coronary syndrome (according to the definitions of guidelines)
• Age \> 18
• written consent
• Caucasian origin
• Affiliation to health care system
• 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):
• Patients hospitalized for an urgent surgery
• Age \> 18
• Written consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fédération Française de Cardiologie: collaborator

Study Sites (1)

Name: Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines

Boulogne-Billancourt, Hautes Des Seine, 92210, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Acute Coronary Syndrome; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Myocardial Ischemia; Vascular Diseases

Study Officials

• Nicolas Mansencal, MD, PHD

  Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: January 30, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: May 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-02

Locations

FR (1)