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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04325321
Other study ID # R01HL149672
Secondary ID R01HL149672
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2, 2020
Est. completion date December 31, 2024

Study information

Verified date March 2023
Source The Miriam Hospital
Contact Elena Salmoirago-Blotcher, MD, PhD
Phone 401-793-8325
Email Elena_Salmoirago-Blotcher@brown.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Newly admitted patients with a validated diagnosis of Takotsubo Syndrome (TS; n=106) will be enrolled from 3 large medical centers in the Providence, Rhode Island area. Between 2 and 4 weeks after discharge, clinically stable patients will undergo an in-person comprehensive interview to identify the events proximal to the onset of TS symptoms, complete a battery of psychosocial questionnaires and undergo a validated laboratory stress protocol. Baseline and reactive changes in measures of autonomic nervous system activity (epinephrine and norepinephrine - primary outcome), and in the secondary outcomes of cardiac vagal control and left ventricular function (ejection fraction; regional and global longitudinal strain assessed with speckle tracking echocardiography) will be assessed. Echocardiographic evaluations will be repeated 12 months thereafter together with information on major adverse cerebrovascular events.


Recruitment information / eligibility

Status Recruiting
Enrollment 106
Est. completion date December 31, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >=18 - A new diagnosis of takotsubo syndrome fulfilling Mayo Clinic criteria - Ability to understand and speak English Exclusion Criteria: - Inability or unwillingness to give informed consent - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Country Name City State
United States The Miriam Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
The Miriam Hospital National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Proportion of patients with major adverse cardiac and cerebrovascular events Composite of death from any cause, recurrence of TS, stroke, transient ischemic attack, and myocardial infarction. 12 months
Primary Mean change (in pg/mL) in plasma epinephrine levels Blood samples for plasma epinephrine are collected 10-min into Baseline, 10-min into Emotion Recall, and 18 minutes into Recovery Phase. Change will be calculated by subtracting Baseline epinephrine levels from Emotion Recall levels. Up to 4 weeks
Primary Mean change (in pg/mL) in plasma norepinephrine levels Blood samples for plasma norepinephrine are collected 10-min into Baseline, 10-min into Emotion Recall, and 18 minutes into Recovery Phase. Change will be calculated by subtracting Baseline epinephrine levels from Emotion Recall norepinephrine levels. Up to 4 weeks
Secondary Change in high frequency power heart rate variability (hf-HRV) in Ln msec (square) High frequency power heart rate variability (hf-HRV) will be determined by averaging high frequency values for 4-min segments within each phase (Baseline, Emotion Recall), and change will be calculated (Emotion Recall minus Baseline). Data will be collected using a Digital Holter ECG Recorder - 5 Lead, 2 Channel. Up to 4 weeks
Secondary Left ventricular ejection fraction (%) A trans-thoracic echocardiogram will be performed with computation of ejection fraction according to current guidelines. 12 months
Secondary Average Global Longitudinal Strain (GLS) Global Longitudinal Strain (GLS) will be assessed using off-line analysis software (TomTec imaging systems). GLS will be calculated as the average left ventricular longitudinal strain across the segments obtained using apical two, three, and four-chamber views. Because myocardial contraction results in left ventricular shortening in systole, GLS is a negative value. 12 months
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