Tako-TSUBO CardiomyopathyNCT01520610
TAKO-TSUBO Cardiomyopathy and Genetic
An observational study of Tako-TSUBO Cardiomyopathy and Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tako-TSUBO Cardiomyopathy, Acute Coronary Syndrome
- How many people
- 530 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- Patients presenting with an acute coronary syndrome (according to the definitions of guidelines)
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- Age > 18
- written consent
- Caucasian origin
- Affiliation to health care system
- Patients hospitalized for an urgent surgery
- Age > 18
- Written consent
- Caucasian origin
- Affiliation to health care system
Who cannot join
- 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 a suspicion of Tako-TSUBO cardiomyopathy
- Patients presenting with a history of Tako-TSUBO cardiomyopathy
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- "Surgical stress" group (age- and sex-matched control group):
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Name: Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines
Boulogne-Billancourt, Hautes Des Seine, 92210
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Tako-TSUBO Cardiomyopathy, Acute Coronary Syndrome
- Keywords
- Tako-TSUBO Cardiomyopathy, Stress Cardiomyopathy, Myocardiopathies, Acute Coronary Syndrome, Gene
- Medical subject headings
- Takotsubo Cardiomyopathy, Acute Coronary Syndrome, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA analysis
To identify genetic polymorphisms in adrenergic pathway responsible for the Tako-TSUBO cardiomyopathy susceptibly
Measured: 48 months
Secondary outcomes (1)
Diagnosis and prognosis of Tako-TSUBO cardiomyopathy
To assess diagnostic criteria of Tako-TSUBO cardiomyopathy To assess the prognosis of Tako-TSUBO cardiomyopathy
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tako-TSUBO CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Française de Cardiologie
- Responsible party
- Sponsor
- Investigators
- Nicolas Mansencal, MD, PHD, Principal investigator, Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520610
- Sponsor's protocol ID
- AOR 10018
- Status last verified
- Feb 2016
- First submitted
- 23 Dec 2011
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms in Catecholamine Pathway Responsible for the Tako-TSUBO Cardiomyopathy Susceptibly (TAKO-GENE)
- ClinicalTrials.gov ID
- NCT01520610
- Acronym / sponsor ID
- AOR 10018
- Conditions
- Tako-TSUBO Cardiomyopathy, Acute Coronary Syndrome
- Keywords
- Tako-TSUBO Cardiomyopathy, Stress Cardiomyopathy, Myocardiopathies, Acute Coronary Syndrome, Gene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fédération Française de Cardiologie
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (11 listed)
- Patients presenting with pheochromocytoma
- Patients presenting with myocarditis
- Patients presenting with subarachnoid hemorrhage
- Patients presenting with a suspicion of Tako-TSUBO cardiomyopathy
- Patients presenting with a history of Tako-TSUBO cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DNA analysis
Time frame: 48 months
To identify genetic polymorphisms in adrenergic pathway responsible for the Tako-TSUBO cardiomyopathy susceptibly
1 secondary outcome
Diagnosis and prognosis of Tako-TSUBO cardiomyopathy
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Mansencal, MD, PHD principal investigator
Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tako-TSUBO Cardiomyopathy and Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA analysis (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.