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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

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
Cardiovascular Diseases Elderly Patients Tooth Extraction

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.

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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 : October 31, 2018
Actual Study Completion Date : March 30, 2019

Group/Cohort
older people with cardiac diseases
undergoing teeth extraction surgery



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population are all older patients with cardiac diseases undergoing teeth extraction surgery.
Criteria

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211312


Locations
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China
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
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Study Director: shaojun ma, master Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University,School of Medicie
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: July 7, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaojun Ma, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
Cardiovascular diseases
Prediction model
Dental extraction
Elderly patients
Additional relevant MeSH terms:
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Cardiovascular Diseases