Prediction Model of Cardiac Risk for Dental Extraction in... | NCT03211312

Studies
Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients With Cardiovascular Diseases

NCT03211312

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Status

Completed

Last Update Posted

Apr 23, 2019Actual

Enrollment

833Actual

Phase

Not provided

Conditions

Cardiovascular Diseases
Elderly Patients
Tooth Extraction

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

Apr 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

May 4, 2018Actual

Primary Completion Date

Oct 31, 2018Actual

Completion Date

Mar 30, 2019Actual

First Submitted Date

Jul 6, 2017

First Submission Date that Met QC Criteria

Jul 6, 2017

First Posted Date

Jul 7, 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

Apr 21, 2019

Last Update Posted Date

Apr 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shaojun Ma, visiting staff, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityPrincipal Investigator

Lead Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study intends to investigate the relevant risk factors of perioperation complications or mortality in older patients with cardiac diseases undergoing teeth extraction surgery and this study aims to quantify the risk factors and then to establish the predictive scoring systems.

Hypothesis:Preoperative parameters could predict postoperative complications.

Detailed Description

This study intends to investigate the relevant risk factors of perioperative complications or mortality in older patients with cardiac diseases undergoing teeth extraction surgery and this study aims to quantify the risk factors and then to establish the predictive scoring systems.

We hope that the benefits will include less patients becoming seriously postoperative complications and mortality after teeth extraction surgery.We also hope the information will help doctors understand the preoperative risks better and therefore make better informed decisions.This may also reduce the overall cost of surgery for patients and hospitals.

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

833Actual

Label	Type	Description	Intervention Names
older people with cardiac diseases		undergoing teeth extraction surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cardiac complications	the cardiac complications during or after dental extraction,such as cardiac events, perioperative SBP ≥180 mmHg, diastolic blood pressure ≥120 mmHg, heart rate ≥120 beats per minute and increase in blood pressure by 20% or above relative to the baseline.	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:1.Adults ≥60 years age 2.Males with cardiac diseases 3.Females with cardiac diseases 4.Listed for teeth extraction surgery

Exclusion Criteria:

1.patient with malignant arrhythmia 2.Age <60 years age 3.Adults with learning disabilities or dementia 4.Patient unwilling/unable to consent 5.Prisoners

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Study population are all older patients with cardiac diseases undergoing teeth extraction surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
shaojun ma, master	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University,School of Medicie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China.		Shanghai		200011	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31048587	Derived	Tang M, Hu P, Wang CF, Yu CQ, Sheng J, Ma SJ. Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients with Cardiovascular Diseases. Gerontology. 2019;65(6):591-598. doi: 10.1159/000497424. Epub 2019 May 2.