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The Cedars-Sinai SHI Takotsubo Registry and Proteomic Study is an observational registry that will collect retrospective and prospective demographic, clinical, hemodynamic, laboratory and other diagnostic parameters, therapy and outcome data from individuals who meet the inclusion/exclusion criteria of Takotsubo Registry protocol. Subjects will also be invited to provide a blood sample utilizing a Mitra kit sent to their homes. Researchers from the Barbra Streisand Women's Heart Center will analyze Registry data to identify Takotsubo phenotypes, improve diagnostic capabilities, better predict recurrence rates, and develop targeted Takotsubo treatments.
Registry outreach will begin with an informational and inspirational website and will utilize social media and patient-driven activism through Facebook, blogs and Twitter modalities that have demonstrated efficiencies in other patient-centered research efforts. Subjects will upload specific clinical materials into Cedar-Sinai's web-enabled cloud storage and which will be screened by trained Smidt Heart Institute physicians. The Registry utilizes on-line, e-consent and enrollment connected to a REDCap database that will allow efficient data input for analysis. All potential subjects who have been diagnosed with Takotsubo or have been informed by their physician that they meet diagnosis criteria, will need to provide information for review that includes: hospitalization records, from the time of Takotsubo event, with laboratory data (particularly -- troponin level), ECG and CTA. Registrants will be asked to respond to annual update surveys.
The goal is to accurately understand the prevalence, recurrence and prospective status of the Takotsubo, to determine which individuals are at risk of reoccurrence or subsequent adverse event and to determine potential treatment targets to develop therapeutic strategies
Primary:
Secondary:
• To establish a clinical trial platform for patient-centered point-of-care trials to improve diagnostics, clinical care and outcomes.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Prevalence of the Takotsubo | Prevalence of the Takotsubo will be measured annually. Change from baseline will be assessed. | Baseline, Annual follow-up up to 30years |
| Number of participants with Recurrence the Takotsubo | Recurrence the Takotsubo will be measured annually. Change from baseline will be assessed. | Baseline, Annual follow-up up to 30years |
| Annual update surveys will collect data on patient's prospective health status following Takotsubo event | Prospective statusof the Takotsubo will be measured annually. Change from baseline will be assessed. | Baseline, Annual follow-up up to 30years |
| Risk factors affecting which patients, having had one Takotsubo event, will more likely experience a Takotsubo reoccurrence or related subsequent adverse event | Risk factors for reoccurrence or subsequent adverse event will be collected annually. | Baseline, Annual follow-up up to 30years |
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Inclusion Criteria:
Exclusion Criteria:
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The registry will be open to all subjects who have experienced a diagnosed Takotsubo syndrome episode or have been informed by their treating physicians that they have the syndrome.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TS Registry | Contact | 310-248-8563 | takotsuboresearch@cshs.org | |
| BS WHC, MS | Contact | 310-423-9666 | bswhc.research@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| C. Noel Bairey Merz, MD, FACC | Cedars-Sinai Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Recruiting | Los Angeles | California | 90005 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39324115 | Derived | Marano P, Maughan J, Obrutu O, Lauzon M, Tjoe B, Herscovici R, Moy P, Rojas N, Shufelt C, Rutledge T, Wei J, Bairey Merz CN. Evaluation of Recurrent Takotsubo Syndrome. JACC Adv. 2024 Sep 17;3(10):101247. doi: 10.1016/j.jacadv.2024.101247. eCollection 2024 Oct. |
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| ID | Term |
|---|---|
| D054549 | Takotsubo Cardiomyopathy |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018487 | Ventricular Dysfunction, Left |
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The blood samples will undergo proteomic analysis.
| D018754 |
| Ventricular Dysfunction |