China STEMI-PCI Program | NCT01716884

Studies
China STEMI-PCI Program

NCT01716884

Sponsor

Peking University First Hospital

Status

Unknown status

Last Update Posted

Oct 30, 2012Estimated

Enrollment

4,000Estimated

Phase

Not provided

Conditions

ST Segment Elevation 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

Oct 2012

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

Dec 2011

Primary Completion Date

Dec 2015Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Oct 26, 2012

First Submission Date that Met QC Criteria

Oct 26, 2012

First Posted Date

Oct 30, 2012Estimated

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

Oct 26, 2012

Last Update Posted Date

Oct 30, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yong Huo, Director of cardiovascular department, Peking University First HospitalPrincipal Investigator

Lead Sponsor

Peking University First HospitalOTHER

Collaborators

Name	Class
Abbott Medical Devices	INDUSTRY
Sanofi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

4,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The reperfusion ratio		up to 1 day

Secondary Outcomes

Measure	Description	Time Frame
Door to Balloon time		up to 1 day
BMS ratio		up to 1 day
health economic evaluation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Onset of STEMI within 12h
Onset of STEMI within 12-36h needing primary PCI

Exclusion Criteria:

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

STEMI Patients enrolled and followed up 1 year

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yan Zhang, MD	Contact	8610-83575180		drzhy1108@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Peking University First Hospital	Recruiting	Beijing		100034	China

Condition Browse Module

MeSH Terms

ID	Term
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided