the Association Between the Arterial Stiffness, Intraoperative Blood Pressure Changes and Genetic EffectNCT05730140
The Association Between the Intraoperative Blood Pressure Changes and Whole Exome Genome
An observational study of the Association Between the Arterial Stiffness, Intraoperative Blood Pressure Changes and Genetic Effect, run by National Taiwan University Hospital.
Trial summary
The intraoperative blood pressure changes have been important for postoperative morbidity and mortality. However, some patients did not occur intraoperative hypotension but some patients would have severe intraoperative hypotension. It may be associated with genome related. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- the Association Between the Arterial Stiffness, Intraoperative Blood Pressure Changes and Genetic Effect
- What is being tested?
- this study did not involve interventions; it only observational study
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2023to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 90 years
- All sexes
- Adult, Older adult
Study population: patients recieving general anesthesia
Who may be able to join
- elective general surgery
Who cannot join
- coagulopathy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Whole Exon Sequencing and Arterial Stiffness in Patients With Intraoperative Hypotension)
The intraoperative blood pressure changes have been important for postoperative morbidity and mortality. However, some patients did not occur intraoperative hypotension but some patients would have severe intraoperative hypotension. It may be associated with genome related. In this hypothesis, we aim to elucidate the association between the whole exome genome and intraoperaive blood pressure changes.
Read the detailed description
We aim to elucidate the association between the whole exome genome and intraoperative blood pressure changes.
We will enroll patients older than 20 years old and undergo elective general anesthesia.
Before anesthesia, we will obtain blood sample for whole exome genome test and give arterial line for intraoperative monitor.
After completing surgery, we will follow the patients' all postoperative major organ function.
We hope this study to be able to give us the more information about the specific genetic effect on the arterial stiffness and intraoperative blood pressure changes.
- Being tested
- this study did not involve interventions; it only observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this study did not involve interventions; it only observational studyOther
this study did not involve interventions. This study is an observational study for elucidating the intraoperative blood pressure changes, artierial stiffness, and whole exome genome
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing general anesthesia | patients undergoing general anesthesia Receives: Other: this study did not involve interventions; it only observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between the arterial stiffness and whole exome genome
using pearson correlation to describe the association
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start10 Feb 2023 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Association Between the Arterial Stiffness, Intraoperative Blood Pressure Changes and Genetic EffectStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730140
- Sponsor's protocol ID
- 202209125RINC
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to ethical concern
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Whole Exon Sequencing and Arterial Stiffness in Patients With Intraoperative Hypotension)
- ClinicalTrials.gov ID
- NCT05730140
- Acronym / sponsor ID
- 202209125RINC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Feb 2023 (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.
The intraoperative blood pressure changes have been important for postoperative morbidity and mortality. However, some patients did not occur intraoperative hypotension but some patients would have severe intraoperative hypotension. It may be associated with genome related. In this hypothesis, we aim to elucidate the association between the whole exome genome and intraoperaive blood pressure changes.
Detailed description
We aim to elucidate the association between the whole exome genome and intraoperative blood pressure changes.
We will enroll patients older than 20 years old and undergo elective general anesthesia.
Before anesthesia, we will obtain blood sample for whole exome genome test and give arterial line for intraoperative monitor.
After completing surgery, we will follow the patients' all postoperative major organ function.
We hope this study to be able to give us the more information about the specific genetic effect on the arterial stiffness and intraoperative blood pressure changes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing general anesthesia | – | Other: this study did not involve interventions; it only observational studypatients undergoing general anesthesia |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients recieving general anesthesia
Key inclusion criteria (1 listed)
- elective general surgery
Key exclusion criteria (1 listed)
- coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| this study did not involve interventions; it only observational studythis study did not involve interventions. This study is an observational study for elucidating the intraoperative blood pressure changes, artierial stiffness, and whole exome genome | Other | patients undergoing general anesthesia |
Primary outcome
The association between the arterial stiffness and whole exome genome
Time frame: 15 minutes
using pearson correlation to describe the association
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No. due to ethical concern
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.
Questions about this trial
What is this clinical trial studying?
An observational study of the Association Between the Arterial Stiffness, Intraoperative Blood Pressure Changes and Genetic Effect, run by National Taiwan University Hospital.
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 1 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: opening soon, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Jun Lai, MD (0223123456 ext. 62158, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between the arterial stiffness and whole exome genome (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.