Pathogenesis of Acute Stress Induced (Tako-tsubo) Cardiomyopathy: Energy Shut-Down or Intense Inflammation?

NCT02897739 | Completed

• 1 other identifier: 14/NS/1068
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Tako Tsubo Cardiomyopathy (TTC), also known as "Broken Heart Syndrome", is a disorder of the heart that occurs most commonly in women (although it occasionally occurs in men) and is usually related to a stressful event. Symptoms are often similar to a heart attack, and include chest pain and shortness of breath. Although Tako Tsubo Cardiomyopathy is not a new medical condition, it has not been widely recognised until the last decade. Currently the investigators don't have an exact understanding of how or why the heart is affected in this way, and so the investigators are conducting a study to help understand what causes Tako Tsubo Cardiomyopathy.

Conditions

Tako-tsubo Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Cardiac Inflammation as measured by Cardiac Magnetic Resonance Imaging

  As measured by cardiac MRI

  Three years

Secondary Outcomes (3)

• Evidence of psycho-emotional factors following intense physical or emotional stress as measured by Hospital Anxiety and Depression Scale

  Three years

• Evidence of alterations of the metabolism of myocardium by Cardiac Positron Emission Tomography

  Three years

• Systemic Inflammation as measured by inflammatory markers

  Three years

Study Arms (2)

TTC Patients

Patients diagnosed with Tako-tsubo cardiomyopathy.

Procedure: Magnetic resonance imaging; Biological: Acute Inflammatory Activation study; Radiation: PET CT; Behavioral: Psychological assessment

Health Volunteers

Participants who have normal hearts.

Procedure: Magnetic resonance imaging; Biological: Acute Inflammatory Activation study; Radiation: PET CT; Behavioral: Psychological assessment

Interventions

Magnetic resonance imaging PROCEDURE

Cardiac MRI and short MRI following USPIO infusion

Health Volunteers; TTC Patients

Acute Inflammatory Activation study BIOLOGICAL

Blood sampling for exploration of type and level of inflammatory response

Health Volunteers; TTC Patients

PET CT RADIATION

PET study for metabolic pathway study

Health Volunteers; TTC Patients

Psychological assessment BEHAVIORAL

Assessment by a psychologist

Health Volunteers; TTC Patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with Tako-tsubo Cardiomyopathy Healthy volunteers

You may qualify if:

• Age and gender matched healthy controls willing to participate and able to give consent.

You may not qualify if:

• Unwillingness to participate
• Patients with contraindications to MR scanning
• Pregnant or breast-feeding women

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

Cardiac Research Office

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

Location

Related Publications (33)

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  PMID: 35861811 DERIVED

• Scally C, Abbas H, Ahearn T, Srinivasan J, Mezincescu A, Rudd A, Spath N, Yucel-Finn A, Yuecel R, Oldroyd K, Dospinescu C, Horgan G, Broadhurst P, Henning A, Newby DE, Semple S, Wilson HM, Dawson DK. Myocardial and Systemic Inflammation in Acute Stress-Induced (Takotsubo) Cardiomyopathy. Circulation. 2019 Mar 26;139(13):1581-1592. doi: 10.1161/CIRCULATIONAHA.118.037975.

  PMID: 30586731 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood samples, EDTA Plasma and Serum to be retained.

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Dana Dawson, MD, MRCP

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: September 13, 2016
• Study Start: August 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 8, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)