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Stress Reactivity Test for Takotsubo Syndrome (BHS Trial)

N/A
Recruiting
Led By Elena Salmoirago-Blotcher, MD, PhD
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A new diagnosis of takotsubo syndrome fulfilling Mayo Clinic criteria
Age >=18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

BHS Trial Summary

This trial is looking at Takotsubo Syndrome, a condition where the heart doesn't pump blood as well as it should. They want to see if stress plays a role in how well patients do after having this condition.

Who is the study for?
The Broken Heart Study II is for adults over 18 with a new diagnosis of Takotsubo Syndrome, who can understand and speak English. It's not suitable for those unable to consent, with severe cognitive issues, uncontrolled high blood pressure, acute psychosis, high suicide risk, pregnancy or poor heart imaging quality.Check my eligibility
What is being tested?
This study investigates the underlying causes of Takotsubo Syndrome (a stress-induced cardiomyopathy) and how stress events affect patients' health one year after diagnosis. Participants will undergo a stress reactivity test as part of the research.See study design
What are the potential side effects?
Since this trial involves a stress reactivity test rather than medication or invasive procedures, side effects may include temporary emotional distress or anxiety due to induced psychological stress.

BHS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been newly diagnosed with takotsubo syndrome.
Select...
I am 18 years old or older.

BHS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change (in pg/mL) in plasma epinephrine levels
Mean change (in pg/mL) in plasma norepinephrine levels
Secondary outcome measures
Average Global Longitudinal Strain (GLS)
Change in high frequency power heart rate variability (hf-HRV) in Ln msec (square)
Left ventricular ejection fraction (%)
Other outcome measures
Proportion of patients with major adverse cardiac and cerebrovascular events

BHS Trial Design

1Treatment groups
Experimental Treatment
Group I: Stress reactivityExperimental Treatment1 Intervention
Stress reactivity test

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,521 Total Patients Enrolled
The Miriam HospitalLead Sponsor
238 Previous Clinical Trials
37,369 Total Patients Enrolled
Elena Salmoirago-Blotcher, MD, PhDPrincipal Investigator - The Miriam Hospital
The Miriam Hospital
3 Previous Clinical Trials
259 Total Patients Enrolled

Media Library

Stress reactivity Clinical Trial Eligibility Overview. Trial Name: NCT04325321 — N/A
Takotsubo Syndrome Research Study Groups: Stress reactivity
Takotsubo Syndrome Clinical Trial 2023: Stress reactivity Highlights & Side Effects. Trial Name: NCT04325321 — N/A
Stress reactivity 2023 Treatment Timeline for Medical Study. Trial Name: NCT04325321 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main aims of this research trial?

"The main metric of success in this trial, which will be observed over a month-long period, is the change (in pg/mL) in plasma norepinephrine levels. Secondary metrics include alterations to High Frequency Power Heart Rate Variability (hf-HRV), Average Global Longitudinal Strain (GLS), and Left Ventricular Ejection Fraction (%). All data collection for these measurements are to occur using Digital Holter ECG Recorder - 5 Lead, 2 Channel., TomTec Imaging Systems Software, and Trans-Thoracic Echocardiogram respectively."

Answered by AI

Are there any opportunities for the public to participate in this experiment?

"Indeed, clinicaltrials.gov confirms that this research endeavour is open for enrolment at present. The initial posting was on September 2nd 2020 and it has been recently updated as of December 14th 2021. 106 individuals will be accepted from a single site"

Answered by AI

How many participants have signed up for this research project?

"Affirmative. According to data on clinicaltrials.gov, this experiment is currently recruiting patients; it was originally posted on September 2nd 2020 and recently updated December 14th 2021. A total of 106 individuals need to be enlisted from 1 medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
The Miriam Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Broken Heart Study II (BHS-II)
Elena Salmoirago-Blotcher 2020. "The Broken Heart Study II (BHS-II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04325321.
All > Cardiomyopathy
~15 spots leftby Nov 2024
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