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ACTIVE NOT RECRUITING
NCT04325321
NA

The Broken Heart Study II (BHS-II)

Sponsor: The Miriam Hospital

View on ClinicalTrials.gov

Summary

The goals of this study are as follows: 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.

Official title: Heterogeneity and Predictors of Stress Reactivity in Takotsubo Syndrome

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2020-09-02

Completion Date

2026-02

Last Updated

2025-04-27

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (1)

The Miriam Hospital

Providence, Rhode Island, United States