Analysis of Incidence and Risk Factors of Severe Cardiova... | NCT03138109

Studies
Analysis of Incidence and Risk Factors of Severe Cardiovascular Events in Patients With Diastolic Dysfunction

NCT03138109

Sponsor

Yan Zhou, MD

Status

Completed

Last Update Posted

Sep 14, 2018Actual

Enrollment

4,347Actual

Phase

Not provided

Conditions

Diastolic Dysfunction

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

Sep 2018

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

Aug 31, 2015Actual

Primary Completion Date

Mar 31, 2017Actual

Completion Date

Mar 31, 2017Actual

First Submitted Date

Apr 30, 2017

First Submission Date that Met QC Criteria

Apr 30, 2017

First Posted Date

May 3, 2017Actual

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

Sep 12, 2018

Last Update Posted Date

Sep 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 retrospective cohort study was intended to analyze the incidence and risk factors of perioperative severe cardiovascular events in patients with diastolic dysfunction.

Detailed Description

The investigators retrospected patients underwent noncardiac surgery with pre-operative echocardiography and was diagnosed with diastolic dysfunction in 2015 in Peking University First Hospital. Patients' perioperative data were collected. Major adverse cardiovascular events(MACE), other complication incidence, and post-operative hospital stay were reviewed. propotional harzad ratio cox survival model was established. Risk and protective factors relative to MACE were analysed.

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

4,347Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
grade1&2 diastolic dysfunction		lower diastolic dysfunction exposure
grade 3 diastolic dysfunction		higher diastolic dysfunction exposure

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	major cardiac complications	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years old or older, with echocardiographic diagnosis of left ventricular diastolic dysfunction (while ejection fraction was > = 50%) conducted by cardiologist within 90 days before surgery.

Exclusion Criteria:

congenital heart disease, moderate to severe valvular disease (stenosis or insufficiency), atrial fibrillation / atrial flutter, pericarditis, unsatisfied cardiac ultrasound image, ejection fraction < 50%, ASA greater than 4, or Echocardiography is missing or incomplete.

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

patients with diastolic dysfunction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yan Zhou, MD, PhD	Peking University First Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First hospital Peking University		Beijing	Beijing Municipality	100034	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19270053	Background	Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, Smiseth OA, Waggoner AD, Flachskampf FA, Pellikka PA, Evangelisa A. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr. 2009 Mar;10(2):165-93. doi: 10.1093/ejechocard/jep007. No abstract available.
12581679	Background