Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
66 participants
INTERVENTIONAL
2020-09-02
2026-02-28
Brief Summary
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1. To rigorously establish and characterize heterogeneity in the pathophysiology of Takotsubo Syndrome (TS).
2. To rigorously test the contribution of TS triggering events and mental stress responsiveness to 1-year prognosis after TS event.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Stress reactivity
Stress reactivity test
Stress reactivity test
The protocol consists of Resting Baseline (BL), Emotion Recall (ER), followed by a Recovery Phase (RP). Heart rate and blood pressure are measured at baseline and then every 5 minutes during ER and RP.
Resting Baseline (BL - 10 min). The participant is instructed to rest quietly.
Emotion Recall (ER - 5-10 min). The participant is instructed to think about the incident associated with the onset of their cardiac event and bring to mind details of the incident. When the participants have the incident clearly in mind, they are instructed to relate the incident and their experience out loud; frequent questions to re-elicit the emotion are asked.
Recovery Phase (RP - 20 min). Upon completion of RP, the catheter is removed and participants are de-instrumented. Blood samples for plasma catecholamines, assessments of heart rate variability, and echocardiograms are performed 10-min into BL, 10-min into ER, and 18 minutes into RP.
Interventions
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Stress reactivity test
The protocol consists of Resting Baseline (BL), Emotion Recall (ER), followed by a Recovery Phase (RP). Heart rate and blood pressure are measured at baseline and then every 5 minutes during ER and RP.
Resting Baseline (BL - 10 min). The participant is instructed to rest quietly.
Emotion Recall (ER - 5-10 min). The participant is instructed to think about the incident associated with the onset of their cardiac event and bring to mind details of the incident. When the participants have the incident clearly in mind, they are instructed to relate the incident and their experience out loud; frequent questions to re-elicit the emotion are asked.
Recovery Phase (RP - 20 min). Upon completion of RP, the catheter is removed and participants are de-instrumented. Blood samples for plasma catecholamines, assessments of heart rate variability, and echocardiograms are performed 10-min into BL, 10-min into ER, and 18 minutes into RP.
Eligibility Criteria
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Inclusion Criteria
* A new diagnosis of takotsubo syndrome fulfilling Mayo Clinic criteria
* Ability to understand and speak English
Exclusion Criteria
* Severe cognitive impairment
* Uncontrolled hypertension
* Acute psychosis
* High suicidal risk
* Pregnancy
* Poor echocardiographic window
* Conditions that would interfere with adherence to study requirements (e.g., ongoing alcohol or substance abuse)
* If the participant is clinically unstable
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
The Miriam Hospital
OTHER
Responsible Party
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Elena Salmoirago-Blotcher
Senior Research Scientist, Associated Professor of Medicine
Principal Investigators
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Elena Salmoirago-Blotcher, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Miriam Hospital
Locations
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The Miriam Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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