Hyperglycemia in Patients With Takotsubo Syndrome

December 24, 2020 updated by: Celestino Sardu, University of Campania "Luigi Vanvitelli"

Blood Glucose Values at Hospital Admission and Clinical Outcomes in Patients With Takotsubo Syndrome: Hyperglycemia Effects on Heart Failure Events and Mortality at 24 Months of Follow-up

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80138
        • Raffaele Marfella

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will be of patients with acute TTC event. The enrolled patients according to inclusion and exclusion criteria will be then divided in normoglycemics vs. hyperglycemics according to blood glucose values at hospital admission.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of HF events
Time Frame: 12 months
To evaluate the number of HF events by clinical visits, telephonic interviews and hospital discharge schedules.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

December 28, 2020

Last Update Submitted That Met QC Criteria

December 24, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02.12.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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