Effect of Thyroid Hormone on Post-Myocardial Infarction R... | NCT03933358

Studies
Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients

NCT03933358

Sponsor

Beijing Friendship Hospital

Status

Unknown status

Last Update Posted

May 3, 2019Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Thyroid
Cardiac Remodeling, Ventricular
STEMI

Interventions

Thyroid hormone levels

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Estimated

Primary Completion Date

Jun 30, 2021Estimated

Completion Date

Jun 30, 2021Estimated

First Submitted Date

Apr 29, 2019

First Submission Date that Met QC Criteria

Apr 29, 2019

First Posted Date

May 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2019

Last Update Posted Date

May 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to determine whether thyroid hormone levels are predictive of cardiac remodeling following myocardial infarction and the prognosis in patients with STEMI receiving primary percutaneous coronary intervention.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Euthyroid			Other: Thyroid hormone levels
Low T3		low triiodothyronine syndrome	Other: Thyroid hormone levels

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thyroid hormone levels	Other	This is an observational study. Exposure: Different thyroid hormone levels.	Euthyroid Low T3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE (major adverse cardiovascular events)	cardiovascular death, re-infarction, revascularization, and stroke	12 months

Secondary Outcomes

Measure	Description	Time Frame
adverse cardiac remodeling	a cut-off value of 12% change in left ventricular end-diastolic volume between the acute and follow-up magnetic resonance scans	6 months
all-cause death	death caused by all reason

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

with a confirmed STEMI diagnosis
undergoing primary percutaneous coronary intervention (presenting <12h after symptom onset)
patients agreed and provided informed consent

Exclusion Criteria:

past history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass graft
past history of heart failure (LVEF<40%) or myocardiopathy or atrial fibrillation
past history of thyroid diseases, or were treated with amiodarone, dopamine, or corticosteroids before hospital admission
contraindicating to cardiac magnetic resonance imaging

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients admitted to Beijing Friendship Hospital with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hongwei Li	Contact	0086 10 63139780		lhw19656@sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Friendship Hospital, Capital Medical University	Recruiting	Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D013959	Thyroid Diseases
D020257	Ventricular Remodeling
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D004700	Endocrine System Diseases
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D009203	Myocardial Infarction

Browse Leaves

Not provided

Browse Branches

Not provided