Clinical Characteristics of Acute Pulmonary Embolism in C... | NCT02214043

Studies
Clinical Characteristics of Acute Pulmonary Embolism in Chinese Population

NCT02214043

Sponsor

Chinese Pulmonary Vascular Disease Research Group

Status

Completed

Last Update Posted

Jan 30, 2018Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Pulmonary Embolism

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Feb 3, 2014

First Submission Date that Met QC Criteria

Aug 11, 2014

First Posted Date

Aug 12, 2014Estimated

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

Jan 28, 2018

Last Update Posted Date

Jan 30, 2018Actual

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

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary end point of the present study was symptomatic, objectively confirmed recurrent fatal or nonfatal VTE.		60 months

Secondary Outcomes

Measure	Description	Time Frame
The second end point was death (all cause death and PE-related death).	If the participant died, the relatives need provided the written medical record on the death.	60 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the symptomatic acute PE confirmed by objective examination

Exclusion Criteria:

congestive heart failure
chronic obstructive pulmonary disease;
a prior documented episode of PE or DVT
renal dysfunction;
a life expectancy of less than 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Acute pulmonary embolism in Chinese population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhihong Liu, Doctor	Chinese pulmonary vascular disease organization group	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center of pumonary vascular diseases		Beijing		100037	China

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Group 2
group 1