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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04684004
Other study ID # 02.12.20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date January 1, 2019

Study information

Verified date December 2020
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with Takotsubo cardiomiopathy (TTC) have over-inflammation and over-sympathetic tone. However, these conditions could cause higher rate of heart failure (HF) events and deaths at 2 years of follow-up. Conversely, hyperglycemia vs. normoglycemia could result in over expression of inflammatory markers and catecholamines thta could result in higher rate of HF and deaths at 2 years of follow-up in TTC patients.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 1, 2019
Est. primary completion date January 1, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - acute onset of a cardiovascular event, usually associated with substernal chest pain, initially regarded as STEMI/evolving coronary syndrome; - cardiac biomarker modifications (creatine kinase-MB and troponin I); - systolic dysfunction, predominantly characterized by akinesia/hypokinesia of the mid-to-distal portion of the left ventricle (LV) chamber, with hyper-contractile basal LV. Exclusion Criteria: - patients with previous previous myocardial infarction; - patients with previous TTC event; - patients affected by chronic kidney, liver, and cerebrovascular diseases.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
To report number of HF events and deaths
In these two cohorts of study authors will evaluate at 2 years of follow-up the number of HF events and of deaths.

Locations

Country Name City State
Italy Raffaele Marfella Naples

Sponsors (1)

Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of HF events To evaluate the number of HF events by clinical visits, telephonic interviews and hospital discharge schedules. 12 months
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