Hyperglycemia in Patients With Takotsubo Syndrome

NCT ID: NCT04684004

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2019-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Takotsubo Cardiomyopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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TTC patients with hyperglycemia

These patients will be hospitalized for TTC acute event. These patients will be characterized by higher blood glucose values at admission, and so defined as hyperglycemics.

To report number of HF events and deaths

Intervention Type OTHER

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

TTC patients with normoglycemia

These patients will be hospitalized for TTC acute event. These patients will be characterized by normal blood glucose values at admission, and so defined as normoglycemics.

To report number of HF events and deaths

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Celestino Sardu

researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Raffaele Marfella

Naples, , Italy

Site Status

Countries

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Italy

References

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Paolisso P, Bergamaschi L, Rambaldi P, Gatta G, Foa A, Angeli F, Fabrizio M, Casella G, Barbieri M, Galie N, Marfella R, Pizzi C, Sardu C. Impact of Admission Hyperglycemia on Heart Failure Events and Mortality in Patients With Takotsubo Syndrome at Long-term Follow-up: Data From HIGH-GLUCOTAKO Investigators. Diabetes Care. 2021 Sep;44(9):2158-2161. doi: 10.2337/dc21-0433. Epub 2021 Jun 29.

Reference Type DERIVED
PMID: 34187841 (View on PubMed)

Other Identifiers

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02.12.20

Identifier Type: -

Identifier Source: org_study_id