NCT03060499

Brief Summary

Protocol Synopsis Protocol title: Post thyroidectomy myocardial function Purpose: Evaluation of the effects of total thyroidectomy on myocardial function Design: Prospective, single-center, cohort study Patient Population: Male or female subjects 18 years of age or older who are scheduled for total thyroidectomy No. of Subjects: 50 patients, estimated up to 12 months to enroll Duration of Treatment: Operation Duration of Follow-up: After discharge, the patients will be re-evaluated at three (3), six (6) and twelve (12) months in the outpatient clinic. Endpoints: To evaluate the changes in the myocardial function after the removal of the thyroid gland.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2018

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

February 16, 2017

Last Update Submit

August 25, 2021

Conditions

ThyroidThyroidectomyMyocardial Function

Keywords

ThyroidectomyMyocardial FunctionThyroid glandHeart

Outcome Measures

Primary Outcomes (1)

  • Echocardiographic Assessment of Changes in Myocardial Function at 3, 6 and 12 months after Thyroidectomy

    They will be assessed at 3, 6 and 12 months after thyroidectomy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study is designed as a prospective, single-center, cohort study. Any patient that is scheduled for a total thyroidectomy in 1st Propedeutic Department of Surgery (AHEPA University General Hospital) will be offered participation in this study if they fulfill the following requirements.

You may qualify if:

  • Patient is over 18 years old
  • Patient scheduled for a non-emergency operation
  • Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
  • No previous cardiologic history
  • Normal PTH values (no transient hypoparathyroidism)

You may not qualify if:

  • Patient is underage ( under 18 years old)
  • Patient had a previous operation at the thyroid or parathyroids
  • Patient inability to participate in follow-up appointments
  • Patient is participating in another clinical trial which may affect this study's outcomes
  • Patient with TSH values outside the range of normal values
  • Pathologic Ca2+ , Vit D, P, PTH, pre- and post-operative values
  • Diabetes Mellitus, Hypertension, History of any heart, lung or systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHEPA University General Hospital, Aristotle University of Thessaloniki

Thessaloniki, 54621, Greece

Location

Related Publications (2)

  • Bengel FM, Nekolla SG, Ibrahim T, Weniger C, Ziegler SI, Schwaiger M. Effect of thyroid hormones on cardiac function, geometry, and oxidative metabolism assessed noninvasively by positron emission tomography and magnetic resonance imaging. J Clin Endocrinol Metab. 2000 May;85(5):1822-7. doi: 10.1210/jcem.85.5.6520.

    PMID: 10843159BACKGROUND

  • Polikar R, Burger AG, Scherrer U, Nicod P. The thyroid and the heart. Circulation. 1993 May;87(5):1435-41. doi: 10.1161/01.cir.87.5.1435.

    PMID: 8490997BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Ioannis Pliakos, Academic Fellow

    1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki

    PRINCIPAL INVESTIGATOR

  • Antonios Michalopoulos, Professor

    1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki

    PRINCIPAL INVESTIGATOR

  • Georgios Efthimiadis, Assistant Professor

    1st Cardiology Unit, AHEPA University General Hospital, Aristotle University of Thessaloniki

    PRINCIPAL INVESTIGATOR

  • Haralambos Karvounis, Professor

    1st Cardiology Unit, AHEPA University General Hospital, Aristotle University of Thessaloniki

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery, Aristotle University of Thessaloniki

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

October 13, 2016

Primary Completion

October 13, 2017

Study Completion

October 13, 2018

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)