MACE and First Operating Room Systolic Blood Pressure in... | NCT03185598

Studies
MACE and First Operating Room Systolic Blood Pressure in Patients Undergoing Non-cardiac Surgery Implications for the Hypertension Threshold

NCT03185598

Sponsor

Peking University First Hospital

Status

Completed

Last Update Posted

Mar 19, 2019Actual

Enrollment

90,342Actual

Phase

Not provided

Conditions

Major Adverse Cardiac-cerebral-kidney Event

Interventions

Not provided

Countries

Not provided

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

Mar 2019

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 1, 2016Actual

Primary Completion Date

Oct 1, 2018Actual

Completion Date

Jan 5, 2019Actual

First Submitted Date

Jun 11, 2017

First Submission Date that Met QC Criteria

Jun 11, 2017

First Posted Date

Jun 14, 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

Mar 18, 2019

Last Update Posted Date

Mar 19, 2019Actual

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

To find the threshold of First operating room SBP above which MACE risk increases.

Detailed Description

To find the threshold of First operating room SBP above which MACE risk increases. By reviewing data from 2012-2017 in PKU first hospital.

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

90,342Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-MACE		no MACE occurred
MACE		MACE occurred

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	major adverse cardiac-cerebral-kidney event	30 days postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-100yr non-cardiac surgery

Exclusion Criteria:

missing data file

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

90342 eligible surgeries among 71164 unique patients included

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided