Tako Tsubo CardiomyopathyTAKO-PROVENCT06669962
Characterisation of the Biochemical Profile and Physiology of the Coronary Circulation in Takotsubo Syndrome
An observational study of Tako Tsubo Cardiomyopathy, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
Consecutive consenting patients over the age of 18 years diagnosed with Takotsubo syndrome according to the position statement of the European Journal of Heart Failure (2016) will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tako Tsubo Cardiomyopathy
- What is being tested?
- Study of coronary microcirculation and biomarkers of microvascular dysfunction
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jul 2024to 27 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive consenting patients over the age of 18 years with a diagnosis of Takotsubo syndrome will be included in the study according to the position statement of the European Journal of Heart Failure (2016).
Who may be able to join
- Age ≥ 18 years;
- Diagnosis of Takotsubo syndrome
- Signing of informed consent
Who cannot join
- Age <18 years;
- Refusal to sign written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Città della Salute e della Scienza
Turin, Turin, 10126
Ovidio De Filippo, +390116336023, odefilippo@cittadellasalute.to.it
About this study
Consecutive consenting patients over the age of 18 years diagnosed with Takotsubo syndrome according to the position statement of the European Journal of Heart Failure (2016) will be included in the study. The primary endpoint is to evaluate the incidence of coronary microcirculation dysfunction and its correlation with the clinical presentation and the prognosis in patients with TAKO-Tsubo syndrome. Secondary endpoints will be to assess the incidence of in-hospital mortality, the prevalence of cardiogenic shock, the correlation between the levels of biomarkers analyzed, microvascular dysfunction, perceived quality of life, and angina severity during hospitalization and at subsequent follow-ups, and the influence of knowledge of the level of microvascular dysfunction on clinical management and prescribed therapies. Enrolment: 2 years, follow-up: 1 month and 1 year. Total: 3 years.
- Conditions
- Tako Tsubo Cardiomyopathy
- Being tested
- Study of coronary microcirculation and biomarkers of microvascular dysfunction
- Medical subject headings
- Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of coronary microcirculation and biomarkers of microvascular dysfunctionDiagnostic test
Patients with tako-tsubo syndrome will undergo to coronary angiography, ventriculography and assessment of physiological indexes of coronary circulation as per clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coronary microcirculation dysfunction
coronary microvascular dysfunztion will be defined as a coronary flow reserve (CFR) < 2.5 and/or as an index of microvascular resistance (IMR) > 25 , as assessed with Coroventis syestem
Measured: one year
Secondary outcomes (4)
Incidence of in-hospital mortality
all-cause death
Measured: up to thirty days
Correlation between the levels of biomarkers analysed and microvascular dysfunction
Several biomarkers (namely neuropeptide Y, troponin I, nt-pro BNP) will be measured via center-specific labratory essays) and a correlation of their blood levels with coronary microvascular dysfunction ( coronary flow reserve (CFR) and index of microvascular resistance (IMR) assessed with Coroventis system) will be sought
Measured: at discharge (assessed up to 5 days)
Perceived quality of life
Assessed with Euro Quality of life scale 5D (EQOL-5d): EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort,and anxiety/depression. The answers given to ED-5D permitto find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possiblehealth status).
Measured: one year
Severity of angina
assessed with the Seattle Angina Questionnaire (SAQ): This SAQ quantifies 5 domains measuring the impact of angina on patients' health status: Physical Limitation (9 items), Angina Stability (1item), Angina Frequency (2 items), Treatment Satisfaction (4 items), and Quality of Life (3 items). Item responses are coded sequentially from worst to best status and range from 1 to 6 for Physical Limitation, Angina Stability, and Angina Frequency items; 1 to 5/6 for Treatment Satisfaction items; and 1 to 5 for Quality of Life items
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start10 Jul 2024
- Primary completion27 Jun 2026 (estimated)
- Study completion27 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669962
- Sponsor's protocol ID
- AOUCitta
- Acronym
- TAKO-PROVE
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of the Biochemical Profile and Physiology of the Coronary Circulation in Takotsubo Syndrome
- ClinicalTrials.gov ID
- NCT06669962
- Acronym / sponsor ID
- TAKO-PROVE / AOUCitta
- Conditions
- Tako Tsubo Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 27 Jun 2026 (estimated)
- Study completion
- 27 Jun 2027 (estimated)
- First posted
- 1 Nov 2024 (actual)
- 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.
Consecutive consenting patients over the age of 18 years diagnosed with Takotsubo syndrome according to the position statement of the European Journal of Heart Failure (2016) will be included in the study. The primary endpoint is to evaluate the incidence of coronary microcirculation dysfunction and its correlation with the clinical presentation and the prognosis in patients with TAKO-Tsubo syndrome. Secondary endpoints will be to assess the incidence of in-hospital mortality, the prevalence of cardiogenic shock, the correlation between the levels of biomarkers analyzed, microvascular dysfunction, perceived quality of life, and angina severity during hospitalization and at subsequent follow-ups, and the influence of knowledge of the level of microvascular dysfunction on clinical management and prescribed therapies. Enrolment: 2 years, follow-up: 1 month and 1 year. Total: 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive consenting patients over the age of 18 years with a diagnosis of Takotsubo syndrome will be included in the study according to the position statement of the European Journal of Heart Failure (2016).
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Diagnosis of Takotsubo syndrome
- Signing of informed consent
Key exclusion criteria (2 listed)
- Age <18 years;
- Refusal to sign written informed consent.
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 |
|---|---|---|
| Study of coronary microcirculation and biomarkers of microvascular dysfunctionPatients with tako-tsubo syndrome will undergo to coronary angiography, ventriculography and assessment of physiological indexes of coronary circulation as per clinical practice | Diagnostic test | – |
Primary outcome
Incidence of coronary microcirculation dysfunction
Time frame: one year
coronary microvascular dysfunztion will be defined as a coronary flow reserve (CFR) < 2.5 and/or as an index of microvascular resistance (IMR) > 25 , as assessed with Coroventis syestem
4 secondary outcomes
Incidence of in-hospital mortality
Time frame: up to thirty days
Correlation between the levels of biomarkers analysed and microvascular dysfunction
Time frame: at discharge (assessed up to 5 days)
Perceived quality of life
Time frame: one year
Severity of angina
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- 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.
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 A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Nov 2024. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ovidio De Filippo, MD (+390116336023, odefilippo@cittadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of coronary microcirculation dysfunction (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2024.