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Post Thyroidectomy Myocardial Function (TECH)

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ClinicalTrials.gov Identifier: NCT03060499
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Papavramidis Theodossis, Aristotle University Of Thessaloniki

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.


Condition or disease
Thyroid Thyroidectomy Myocardial Function

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Thyroidectomy Myocardial Function
Actual Study Start Date : October 13, 2016
Estimated Primary Completion Date : October 13, 2017
Estimated Study Completion Date : October 13, 2018



Primary Outcome Measures :
  1. Echocardiographic Assessment of Changes in Myocardial Function at 3, 6 and 12 months after Thyroidectomy [ Time Frame: They will be assessed at 3, 6 and 12 months after thyroidectomy. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060499


Contacts
Contact: Theodossis Papavramidis, Assistant Professor 00306944536972 papavramidis@hotmail.com

Locations
Greece
AHEPA University General Hospital, Aristotle University of Thessaloniki Recruiting
Thessaloniki, Greece, 54621
Contact: Theodossis Papavramidis, Assistant Professor         
Principal Investigator: Ioannis Pliakos, Academic Fellow         
Principal Investigator: Antonios Michalopoulos, Professor         
Principal Investigator: Georgios Efthimiadis, Assistant Professor         
Principal Investigator: Haralambos Karvounis, Professor         
Sub-Investigator: Angeliki Chorti, Medical Student         
Sub-Investigator: Aristi Boulmpou, Medical Student         
Sub-Investigator: Samer Abu-farha, Resident         
Sub-Investigator: Thomas Zegkos, Resident         
Sub-Investigator: Triantafyllia Boutsiadou, Resident         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: 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

Publications:
Responsible Party: Papavramidis Theodossis, Assistant Professor of Surgery, Aristotle University of Thessaloniki, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03060499     History of Changes
Other Study ID Numbers: 584/13.10.2016
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Papavramidis Theodossis, Aristotle University Of Thessaloniki:
Thyroidectomy
Myocardial Function
Thyroid gland
Heart