Evaluation of Novel Risk Factors and Clinical Outcomes of... | NCT02641184

Studies
Evaluation of Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction

NCT02641184

Sponsor

Zhejiang Provincial People's Hospital

Status

Unknown status

Last Update Posted

Feb 17, 2016Estimated

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Coronary Artery Disease
Percutaneous Coronary Intervention
Acute Myocardial Infarction

Interventions

Not provided

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

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Not provided

First Submitted Date

Dec 14, 2015

First Submission Date that Met QC Criteria

Dec 28, 2015

First Posted Date

Dec 29, 2015Estimated

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

Feb 13, 2016

Last Update Posted Date

Feb 17, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiao Ye, MD, Doctor, Zhejiang Provincial People's HospitalPrincipal Investigator

Lead Sponsor

Zhejiang Provincial People's HospitalOTHER

Collaborators

Name	Class
Yangzhou No.1 People's Hospital	OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	OTHER
Huai'an First People's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 aim of this study is to investigate the potential novel risk factors for acute myocardial infarction. Predictors of poor outcomes will be also evaluated.

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

Retention

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major adverse cardiovascular events (MACE)	Composite of angina pectoris, reinfarction, unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up	maximum 5 years

Secondary Outcomes

Measure	Description	Time Frame
Length of hospital stay	The length of in-hospital stay is counted as a secondary outcome	in the phase of hospital stay, maximum 30 days
New-onset diabetes	New-onset diabetes are defined as newly-diagnosed type 2 diabetes mellitus

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Less than 12 hours after the onset of myocardial infarction symptoms
Myocardial necrosis, as evidenced by increased Creatine Kinase Isoenzyme (CK-MB) or troponin levels

Exclusion Criteria:

Age under 18 years-old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients presenting to an emergency room and diagnosed as acute myocardial infarction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Baiming Qu, MD	Department of Cardiology, Zhejiang Provincial People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhejiang provincial people's hospital		Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D009203	Myocardial Infarction
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D007238	Infarction
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

Browse Leaves

Not provided

Browse Branches

Not provided