Acute Coronary Syndrome Clinical Trial
Official title:
Genetic Polymorphisms in Catecholamine Pathway Responsible for the Tako-TSUBO Cardiomyopathy Susceptibly (TAKO-GENE)
Verified date | February 2016 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 530 |
Est. completion date | May 2016 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
"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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Name: Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines | Boulogne Billancourt | Hautes des Seine |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Fédération Française de Cardiologie |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DNA analysis | To identify genetic polymorphisms in adrenergic pathway responsible for the Tako-TSUBO cardiomyopathy susceptibly | 48 months | No |
Secondary | Diagnosis and prognosis of Tako-TSUBO cardiomyopathy | To assess diagnostic criteria of Tako-TSUBO cardiomyopathy To assess the prognosis of Tako-TSUBO cardiomyopathy | 48 months | No |
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