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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211312
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Shaojun Ma, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Tracking Information
First Submitted Date July 6, 2017
First Posted Date July 7, 2017
Last Update Posted Date April 23, 2019
Actual Study Start Date May 4, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2019)
cardiac complications [ Time Frame: 7 days ]
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.
Original Primary Outcome Measures
 (submitted: July 6, 2017)
postoperative complications [ Time Frame: 7 days ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients With Cardiovascular Diseases
Official Title Risk Factors and Prediction Model of Elderly Patients With Cardiovascular Diseases Undergoing Teeth Extraction Surgery
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study population are all older patients with cardiac diseases undergoing teeth extraction surgery.
Condition
  • Cardiovascular Diseases
  • Elderly Patients
  • Tooth Extraction
Intervention Not Provided
Study Groups/Cohorts older people with cardiac diseases
undergoing teeth extraction surgery
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 21, 2019)
833
Original Estimated Enrollment
 (submitted: July 6, 2017)
500
Actual Study Completion Date March 30, 2019
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03211312
Other Study ID Numbers Shanghai9th
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Shaojun Ma, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study Sponsor Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators Not Provided
Investigators
Study Director: shaojun ma, master Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University,School of Medicie
PRS Account Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Verification Date April 2019