The Contemporary Role of Beta Blockers in Patients With A... | NCT04564365

Studies
The Contemporary Role of Beta Blockers in Patients With Acute Myocardial Infarction

NCT04564365

Sponsor

Chongqing Medical University

Status

Unknown status

Last Update Posted

Nov 11, 2021Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

beta-blocker

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

Jun 2021

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

Jun 30, 2019Actual

Primary Completion Date

Nov 25, 2021Estimated

Completion Date

Dec 25, 2021Estimated

First Submitted Date

Sep 22, 2020

First Submission Date that Met QC Criteria

Sep 22, 2020

First Posted Date

Sep 25, 2020Actual

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

Nov 9, 2021

Last Update Posted Date

Nov 11, 2021Actual

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

The use of beta blockers after acute myocardial infarction is a core component of drug therapy, but evidence is primarily derived from patients who did not receive reperfusion therapy and secondary prophylaxis.In contemporary times, the prognostic value of beta blockers in patients with acute myocardial infarction has been questioned, particularly in patients without reduced heart failure/ejection fraction after acute myocardial infarction.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
with beta-blocker			Drug: beta-blocker
without beta-blocker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
beta-blocker	Drug	To investigate the relationship between the use of beta blockers and prognosis in patients with normal ejection fraction after acute myocardial infarction	with beta-blocker

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality	all-cause mortality	the median time of 8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The diagnosis of acute myocardial infarction was clear and the left ventricular ejection fraction was normal

Exclusion Criteria:

History of heart failure Died in hospital

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

The patient had normal left ventricular ejection fraction (LVEF≥50%) after acute myocardial infarction.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first affiliated Hospital of Chongqing Medical University	Recruiting	Chongqing		400042	China

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000319	Adrenergic beta-Antagonists

Ancestor Terms

ID	Term
D018674	Adrenergic Antagonists
D018663	Adrenergic Agents
D018377	Neurotransmitter Agents
D045504	Molecular Mechanisms of Pharmacological Action

Browse Leaves

Not provided

Browse Branches

Not provided