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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03211312
Other study ID # Shanghai9th
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 4, 2018
Est. completion date March 30, 2019

Study information

Verified date April 2019
Source Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 833
Est. completion date March 30, 2019
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group 60 Years to 100 Years
Eligibility 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

Study Design


Locations

Country Name City State
China Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China. Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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