Cardiovascular DiseasesNCT03211312
Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients With Cardiovascular Diseases
An observational study of Cardiovascular Diseases and Elderly Patients, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Elderly Patients, Tooth Extraction
- How many people
- 833 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2018to 30 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population are all older patients with cardiac diseases undergoing teeth extraction surgery.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China.
Shanghai, 200011
About this study
Official title: Risk Factors and Prediction Model of Elderly Patients With Cardiovascular Diseases Undergoing Teeth Extraction Surgery
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Elderly Patients, Tooth Extraction
- Keywords
- Cardiovascular diseases, Prediction model, Dental extraction, Elderly patients
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| older people with cardiac diseases | undergoing teeth extraction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start4 May 2018
- Primary completion31 Oct 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 833 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaojun Ma, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- shaojun ma, master, Study director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University,School of Medicie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211312
- Sponsor's protocol ID
- Shanghai9th
- Status last verified
- Apr 2019
- First submitted
- 6 Jul 2017
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31048587
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Prediction Model of Elderly Patients With Cardiovascular Diseases Undergoing Teeth Extraction Surgery
- ClinicalTrials.gov ID
- NCT03211312
- Acronym / sponsor ID
- Shanghai9th
- Conditions
- Cardiovascular Diseases, Elderly Patients, Tooth Extraction
- Keywords
- Cardiovascular diseases, Prediction model, Dental extraction, Elderly patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 833 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| older people with cardiac diseases | – | –undergoing teeth extraction surgery |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population are all older patients with cardiac diseases undergoing teeth extraction surgery.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Derived from this study: PubMed 31048587Tang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shaojun ma, master study director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University,School of Medicie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Elderly Patients, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac complications (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03211312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.