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

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
Overall Status
Completed
CT.gov ID
NCT03211312
Collaborator
(none)
833
Enrollment
1
Location
10.8
Actual Duration (Months)
76.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    833 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Risk Factors and Prediction Model of Elderly Patients With Cardiovascular Diseases Undergoing Teeth Extraction Surgery
    Actual Study Start Date :
    May 4, 2018
    Actual Primary Completion Date :
    Oct 31, 2018
    Actual Study Completion Date :
    Mar 30, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    older people with cardiac diseases

    undergoing teeth extraction surgery

    Outcome Measures

    Primary Outcome Measures

    1. cardiac complications [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China. Shanghai China 200011

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shaojun Ma, visiting staff, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    ClinicalTrials.gov Identifier:
    NCT03211312
    Other Study ID Numbers:
    • Shanghai9th
    First Posted:
    Jul 7, 2017
    Last Update Posted:
    Apr 23, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shaojun Ma, visiting staff, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    Cardiovascular diseases
    Prediction model
    Dental extraction
    Elderly patients
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Apr 23, 2019