Tako-tsubo CardiomyopathyTERRIFICNCT02897739
Pathogenesis of Acute Stress Induced (Tako-tsubo) Cardiomyopathy: Energy Shut-Down or Intense Inflammation?
An observational study of Tako-tsubo Cardiomyopathy, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Tako-tsubo Cardiomyopathy
- What is being tested?
- Magnetic resonance imaging, Acute Inflammatory Activation study and PET CT
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 77 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Mar 2019
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have been diagnosed with Tako-tsubo Cardiomyopathy Healthy volunteers
Who may be able to join
- All patients diagnosed with TTC in the past 12 days, able to give consent and who have not lost capacity of consent between the time of diagnosis (usually made at coronary catheterisation, for which they are consented clinically) and time of being approached for inclusion in the study.
- Age and gender matched healthy controls willing to participate and able to give consent.
Who cannot join
- Unwillingness to participate
- Patients with contraindications to MR scanning
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiac Research Office
Aberdeen, Aberdeenshire, AB25 2ZD
About this study
Official title: Pathogenesis of Acute Stress Induced (Tako-tsubo) Cardiomyopathy: Energy Shut-Down or Intense Inflammation? The TERRIFIC Study
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.
Read the detailed description
The investigators aim to study the reciprocal modulation of fatty acids and glucose metabolism in the Tako Tsubo Cardiomyopathy physiology, in both humans and an animal model, and to investigate which metabolic pathway is preferentially adopted by acute Tako Tsubo Cardiomyopathy myocytes during this severe functional shut down with largely preserved variability. The human model will be used to determine the preferential stimulated uptake of glucose/fatty acids under optimal metabolic conditions for each (hyperinsulineamic euglycemic clamp for 18F-Fludeoxyglucose (18F-FDG) and fasting for 14Fluorine-18Fluoro-6-Thia-Heptadecanoic Acid (18F-FTHA cardiac Positron Emission Tomography)). In the rat model the investigators will examine both the metabolic tracer uptake (using micro Positron Emission Tomography-Computed Tomography) as well as the downstream modulation of the two metabolic pathways (transcriptional regulators, mitochondrial respiration, expression of the uncoupling proteins, levels of Adenosine Triphosphate generation and reactive oxygen species production).
The investigators aim to test the hypothesis that inflammation plays a pivotal role in the pathophysiology of this condition by further exploring: 1) In the rat model define time course, extent and subtypes of cellular infiltrate, 2) In the rat model of Tako Tsubo Cardiomyopathy, demonstrate the presence of inflammatory macrophages using in-vivo Ultrasmall Superparamagnetic Iron Oxide-cardiac magnetic resonance imaging and whether this relates to numbers and types of macrophages present as determined by immunohistochemical analysis, 3) In clinical patients, define the time course of specific peripheral blood monocyte subsets and the serum levels of inflammatory cytokines versus matched controls and 4) In clinical patients, establish the compartmentalisation of tissue macrophages in the left ventricle its time course resolution using Ultrasmall Superparamagnetic Iron Oxide-enhanced cardiac magnetic resonance.
The investigators will assess the psycho-emotional factors involved in Tako Tsubo Cardiomyopathy given that in the majority of cases intense emotional trauma is immediately preceding onset.
- Conditions
- Tako-tsubo Cardiomyopathy
- Being tested
- Magnetic resonance imaging, Acute Inflammatory Activation study, PET CT, Psychological assessment
- Medical subject headings
- Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingProcedure or surgery
Cardiac MRI and short MRI following USPIO infusion
Acute Inflammatory Activation studyBiological
Blood sampling for exploration of type and level of inflammatory response
PET CTRadiation
PET study for metabolic pathway study
Psychological assessmentBehavioural
Assessment by a psychologist
| Study group | Role | What they receive |
|---|---|---|
| TTC Patients | Patients diagnosed with Tako-tsubo cardiomyopathy. Receives: Procedure: Magnetic resonance imaging; Biological: Acute Inflammatory Activation study; Radiation: PET CT; Behavioral: Psychological assessment | |
| Health Volunteers | Participants who have normal hearts. Receives: Procedure: Magnetic resonance imaging; Biological: Acute Inflammatory Activation study; Radiation: PET CT; Behavioral: Psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Inflammation as measured by Cardiac Magnetic Resonance Imaging
As measured by cardiac MRI
Measured: Three years
Secondary outcomes (3)
Evidence of psycho-emotional factors following intense physical or emotional stress as measured by Hospital Anxiety and Depression Scale
As measured by psychiatric interview
Measured: Three years
Evidence of alterations of the metabolism of myocardium by Cardiac Positron Emission Tomography
As measured by PET CT
Measured: Three years
Systemic Inflammation as measured by inflammatory markers
As measured by inflammatory markers
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startAug 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Tako-tsubo CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Dana Dawson, MD, MRCP, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897739
- Sponsor's protocol ID
- 14/NS/1068
- Acronym
- TERRIFIC
- Status last verified
- May 2019
- First submitted
- 24 Mar 2016
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Prasad A, Lerman A, Rihal CS. Apical ballooning syndrome (Tako-Tsubo or stress cardiomyopathy): a mimic of acute myocardial infarction. Am Heart J. 2008 Mar;155(3):408-17. doi: 10.1016/j.ahj.2007.11.008. Epub 2008 Jan 31.
PubMed 18294473Gianni M, Dentali F, Grandi AM, Sumner G, Hiralal R, Lonn E. Apical ballooning syndrome or takotsubo cardiomyopathy: a systematic review. Eur Heart J. 2006 Jul;27(13):1523-9. doi: 10.1093/eurheartj/ehl032. Epub 2006 May 23.
PubMed 16720686Neil C, Nguyen TH, Kucia A, Crouch B, Sverdlov A, Chirkov Y, Mahadavan G, Selvanayagam J, Dawson D, Beltrame J, Zeitz C, Unger S, Redpath T, Frenneaux M, Horowitz J. Slowly resolving global myocardial inflammation/oedema in Tako-Tsubo cardiomyopathy: evidence from T2-weighted cardiac MRI. Heart. 2012 Sep;98(17):1278-84. doi: 10.1136/heartjnl-2011-301481. Epub 2012 Jul 11.
PubMed 22791656Sharkey SW, Windenburg DC, Lesser JR, Maron MS, Hauser RG, Lesser JN, Haas TS, Hodges JS, Maron BJ. Natural history and expansive clinical profile of stress (tako-tsubo) cardiomyopathy. J Am Coll Cardiol. 2010 Jan 26;55(4):333-41. doi: 10.1016/j.jacc.2009.08.057.
PubMed 20117439Abraham J, Mudd JO, Kapur NK, Klein K, Champion HC, Wittstein IS. Stress cardiomyopathy after intravenous administration of catecholamines and beta-receptor agonists. J Am Coll Cardiol. 2009 Apr 14;53(15):1320-5. doi: 10.1016/j.jacc.2009.02.020.
PubMed 19358948Nef HM, Mollmann H, Akashi YJ, Hamm CW. Mechanisms of stress (Takotsubo) cardiomyopathy. Nat Rev Cardiol. 2010 Apr;7(4):187-93. doi: 10.1038/nrcardio.2010.16. Epub 2010 Mar 2.
PubMed 20195267Elesber AA, Prasad A, Lennon RJ, Wright RS, Lerman A, Rihal CS. Four-year recurrence rate and prognosis of the apical ballooning syndrome. J Am Coll Cardiol. 2007 Jul 31;50(5):448-52. doi: 10.1016/j.jacc.2007.03.050. Epub 2007 Jul 16.
PubMed 17662398Neubauer S, Horn M, Naumann A, Tian R, Hu K, Laser M, Friedrich J, Gaudron P, Schnackerz K, Ingwall JS, et al. Impairment of energy metabolism in intact residual myocardium of rat hearts with chronic myocardial infarction. J Clin Invest. 1995 Mar;95(3):1092-100. doi: 10.1172/JCI117756.
PubMed 7883957Dawson DK, Neil CJ, Henning A, Cameron D, Jagpal B, Bruce M, Horowitz J, Frenneaux MP. The Authors Reply. JACC Cardiovasc Imaging. 2016 May;9(5):633. doi: 10.1016/j.jcmg.2015.02.032. Epub 2016 Feb 17. No abstract available.
PubMed 26897679Feola M, Chauvie S, Rosso GL, Biggi A, Ribichini F, Bobbio M. Reversible impairment of coronary flow reserve in takotsubo cardiomyopathy: a myocardial PET study. J Nucl Cardiol. 2008 Nov-Dec;15(6):811-7. doi: 10.1007/BF03007363. Epub 2008 Jul 31.
PubMed 18984457Yoshida T, Hibino T, Kako N, Murai S, Oguri M, Kato K, Yajima K, Ohte N, Yokoi K, Kimura G. A pathophysiologic study of tako-tsubo cardiomyopathy with F-18 fluorodeoxyglucose positron emission tomography. Eur Heart J. 2007 Nov;28(21):2598-604. doi: 10.1093/eurheartj/ehm401. Epub 2007 Oct 7.
PubMed 17921529Ibrahim T, Nekolla SG, Langwieser N, Rischpler C, Groha P, Laugwitz KL, Schwaiger M. Simultaneous positron emission tomography/magnetic resonance imaging identifies sustained regional abnormalities in cardiac metabolism and function in stress-induced transient midventricular ballooning syndrome: a variant of Takotsubo cardiomyopathy. Circulation. 2012 Nov 20;126(21):e324-6. doi: 10.1161/CIRCULATIONAHA.112.134346. No abstract available.
PubMed 23169256Gerber BL, Ordoubadi FF, Wijns W, Vanoverschelde JL, Knuuti MJ, Janier M, Melon P, Blanksma PK, Bol A, Bax JJ, Melin JA, Camici PG. Positron emission tomography using(18)F-fluoro-deoxyglucose and euglycaemic hyperinsulinaemic glucose clamp: optimal criteria for the prediction of recovery of post-ischaemic left ventricular dysfunction. Results from the European Community Concerted Action Multicenter study on use of(18)F-fluoro-deoxyglucose Positron Emission Tomography for the Detection of Myocardial Viability. Eur Heart J. 2001 Sep;22(18):1691-701. doi: 10.1053/euhj.2000.2585.
PubMed 11511119Herrero P, Peterson LR, McGill JB, Matthew S, Lesniak D, Dence C, Gropler RJ. Increased myocardial fatty acid metabolism in patients with type 1 diabetes mellitus. J Am Coll Cardiol. 2006 Feb 7;47(3):598-604. doi: 10.1016/j.jacc.2005.09.030. Epub 2006 Jan 18.
PubMed 16458143Kurisu S, Inoue I, Kawagoe T, Ishihara M, Shimatani Y, Nishioka K, Umemura T, Nakamura S, Yoshida M, Sato H. Myocardial perfusion and fatty acid metabolism in patients with tako-tsubo-like left ventricular dysfunction. J Am Coll Cardiol. 2003 Mar 5;41(5):743-8. doi: 10.1016/s0735-1097(02)02924-8.
PubMed 12628716
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenesis of Acute Stress Induced (Tako-tsubo) Cardiomyopathy: Energy Shut-Down or Intense Inflammation? The TERRIFIC Study
- ClinicalTrials.gov ID
- NCT02897739
- Acronym / sponsor ID
- TERRIFIC / 14/NS/1068
- Conditions
- Tako-tsubo Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- Aug 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators aim to study the reciprocal modulation of fatty acids and glucose metabolism in the Tako Tsubo Cardiomyopathy physiology, in both humans and an animal model, and to investigate which metabolic pathway is preferentially adopted by acute Tako Tsubo Cardiomyopathy myocytes during this severe functional shut down with largely preserved variability. The human model will be used to determine the preferential stimulated uptake of glucose/fatty acids under optimal metabolic conditions for each (hyperinsulineamic euglycemic clamp for 18F-Fludeoxyglucose (18F-FDG) and fasting for 14Fluorine-18Fluoro-6-Thia-Heptadecanoic Acid (18F-FTHA cardiac Positron Emission Tomography)). In the rat model the investigators will examine both the metabolic tracer uptake (using micro Positron Emission Tomography-Computed Tomography) as well as the downstream modulation of the two metabolic pathways (transcriptional regulators, mitochondrial respiration, expression of the uncoupling proteins, levels of Adenosine Triphosphate generation and reactive oxygen species production).
The investigators aim to test the hypothesis that inflammation plays a pivotal role in the pathophysiology of this condition by further exploring: 1) In the rat model define time course, extent and subtypes of cellular infiltrate, 2) In the rat model of Tako Tsubo Cardiomyopathy, demonstrate the presence of inflammatory macrophages using in-vivo Ultrasmall Superparamagnetic Iron Oxide-cardiac magnetic resonance imaging and whether this relates to numbers and types of macrophages present as determined by immunohistochemical analysis, 3) In clinical patients, define the time course of specific peripheral blood monocyte subsets and the serum levels of inflammatory cytokines versus matched controls and 4) In clinical patients, establish the compartmentalisation of tissue macrophages in the left ventricle its time course resolution using Ultrasmall Superparamagnetic Iron Oxide-enhanced cardiac magnetic resonance.
The investigators will assess the psycho-emotional factors involved in Tako Tsubo Cardiomyopathy given that in the majority of cases intense emotional trauma is immediately preceding onset.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TTC Patients | – | Procedure: Magnetic resonance imaging, Biological: Acute Inflammatory Activation study, Radiation: PET CT, Behavioral: Psychological assessmentPatients diagnosed with Tako-tsubo cardiomyopathy. |
| Health Volunteers | – | Procedure: Magnetic resonance imaging, Biological: Acute Inflammatory Activation study, Radiation: PET CT, Behavioral: Psychological assessmentParticipants who have normal hearts. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with Tako-tsubo Cardiomyopathy Healthy volunteers
Key inclusion criteria (2 listed)
- All patients diagnosed with TTC in the past 12 days, able to give consent and who have not lost capacity of consent between the time of diagnosis (usually made at coronary catheterisation, for which they are consented clinically) and time of being approached for inclusion in the study.
- Age and gender matched healthy controls willing to participate and able to give consent.
Key exclusion criteria (3 listed)
- Unwillingness to participate
- Patients with contraindications to MR scanning
- Pregnant or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingCardiac MRI and short MRI following USPIO infusion | Procedure or surgery | Health Volunteers, TTC Patients |
| Acute Inflammatory Activation studyBlood sampling for exploration of type and level of inflammatory response | Biological | Health Volunteers, TTC Patients |
| PET CTPET study for metabolic pathway study | Radiation | Health Volunteers, TTC Patients |
| Psychological assessmentAssessment by a psychologist | Behavioural | Health Volunteers, TTC Patients |
Primary outcome
Cardiac Inflammation as measured by Cardiac Magnetic Resonance Imaging
Time frame: Three years
As measured by cardiac MRI
3 secondary outcomes
Evidence of psycho-emotional factors following intense physical or emotional stress as measured by Hospital Anxiety and Depression Scale
Time frame: Three years
Evidence of alterations of the metabolism of myocardium by Cardiac Positron Emission Tomography
Time frame: Three years
Systemic Inflammation as measured by inflammatory markers
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Background: PubMed 18294473Prasad A, Lerman A, Rihal CS. Apical ballooning syndrome (Tako-Tsubo or stress cardiomyopathy): a mimic of acute myocardial infarction. Am Heart J. 2008 Mar;155(3):408-17. doi: 10.1016/j.ahj.2007.11.008. Epub 2008 Jan 31.
- Background: PubMed 16720686Gianni M, Dentali F, Grandi AM, Sumner G, Hiralal R, Lonn E. Apical ballooning syndrome or takotsubo cardiomyopathy: a systematic review. Eur Heart J. 2006 Jul;27(13):1523-9. doi: 10.1093/eurheartj/ehl032. Epub 2006 May 23.
- Background: PubMed 22791656Neil C, Nguyen TH, Kucia A, Crouch B, Sverdlov A, Chirkov Y, Mahadavan G, Selvanayagam J, Dawson D, Beltrame J, Zeitz C, Unger S, Redpath T, Frenneaux M, Horowitz J. Slowly resolving global myocardial inflammation/oedema in Tako-Tsubo cardiomyopathy: evidence from T2-weighted cardiac MRI. Heart. 2012 Sep;98(17):1278-84. doi: 10.1136/heartjnl-2011-301481. Epub 2012 Jul 11.
- Background: PubMed 20117439Sharkey SW, Windenburg DC, Lesser JR, Maron MS, Hauser RG, Lesser JN, Haas TS, Hodges JS, Maron BJ. Natural history and expansive clinical profile of stress (tako-tsubo) cardiomyopathy. J Am Coll Cardiol. 2010 Jan 26;55(4):333-41. doi: 10.1016/j.jacc.2009.08.057.
- Background: PubMed 19358948Abraham J, Mudd JO, Kapur NK, Klein K, Champion HC, Wittstein IS. Stress cardiomyopathy after intravenous administration of catecholamines and beta-receptor agonists. J Am Coll Cardiol. 2009 Apr 14;53(15):1320-5. doi: 10.1016/j.jacc.2009.02.020.
- Background: PubMed 20195267Nef HM, Mollmann H, Akashi YJ, Hamm CW. Mechanisms of stress (Takotsubo) cardiomyopathy. Nat Rev Cardiol. 2010 Apr;7(4):187-93. doi: 10.1038/nrcardio.2010.16. Epub 2010 Mar 2.
- Background: PubMed 17662398Elesber AA, Prasad A, Lennon RJ, Wright RS, Lerman A, Rihal CS. Four-year recurrence rate and prognosis of the apical ballooning syndrome. J Am Coll Cardiol. 2007 Jul 31;50(5):448-52. doi: 10.1016/j.jacc.2007.03.050. Epub 2007 Jul 16.
- Background: PubMed 7883957Neubauer S, Horn M, Naumann A, Tian R, Hu K, Laser M, Friedrich J, Gaudron P, Schnackerz K, Ingwall JS, et al. Impairment of energy metabolism in intact residual myocardium of rat hearts with chronic myocardial infarction. J Clin Invest. 1995 Mar;95(3):1092-100. doi: 10.1172/JCI117756.
- Background: PubMed 26897679Dawson DK, Neil CJ, Henning A, Cameron D, Jagpal B, Bruce M, Horowitz J, Frenneaux MP. The Authors Reply. JACC Cardiovasc Imaging. 2016 May;9(5):633. doi: 10.1016/j.jcmg.2015.02.032. Epub 2016 Feb 17. No abstract available.
- Background: PubMed 18984457Feola M, Chauvie S, Rosso GL, Biggi A, Ribichini F, Bobbio M. Reversible impairment of coronary flow reserve in takotsubo cardiomyopathy: a myocardial PET study. J Nucl Cardiol. 2008 Nov-Dec;15(6):811-7. doi: 10.1007/BF03007363. Epub 2008 Jul 31.
- Background: PubMed 17921529Yoshida T, Hibino T, Kako N, Murai S, Oguri M, Kato K, Yajima K, Ohte N, Yokoi K, Kimura G. A pathophysiologic study of tako-tsubo cardiomyopathy with F-18 fluorodeoxyglucose positron emission tomography. Eur Heart J. 2007 Nov;28(21):2598-604. doi: 10.1093/eurheartj/ehm401. Epub 2007 Oct 7.
- Background: PubMed 23169256Ibrahim T, Nekolla SG, Langwieser N, Rischpler C, Groha P, Laugwitz KL, Schwaiger M. Simultaneous positron emission tomography/magnetic resonance imaging identifies sustained regional abnormalities in cardiac metabolism and function in stress-induced transient midventricular ballooning syndrome: a variant of Takotsubo cardiomyopathy. Circulation. 2012 Nov 20;126(21):e324-6. doi: 10.1161/CIRCULATIONAHA.112.134346. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Dawson, MD, MRCP principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tako-tsubo Cardiomyopathy, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Inflammation as measured by Cardiac Magnetic Resonance Imaging (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02897739, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.