HemodialysisCAD in HDNCT06661941
Predictive Tools for the Presence of Significant Coronary Artery Disease Requiring Intervention in Chronic Hemodialysis Patients
An observational study of Hemodialysis and Coronary Arterial Disease (CAD), run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Medical record data of all HD patients undergoing coronary angiography (CAG) at King Chulalongkorn Memorial Hospital between January 2017 and March 2021 were retrospectively reviewed as a discovery cohort to identify factors discriminating patients with and without significant CAG-established CAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Coronary Arterial Disease (CAD), ESRD (End Stage Renal Disease)
- How many people
- 149 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2017to 31 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult HD patients undergoing CAG at King Chulalongkorn Memorial Hospital of all indications between January 2017 and March 2021 with complete data
Who may be able to join
- All adult HD patients undergoing CAG at King Chulalongkorn Memorial Hospital of all indications between January 2017 and March 2021 with complete data
Who cannot join
- Those resinged for using their clinical data for the research
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330
About this study
Medical record data of all HD patients undergoing coronary angiography (CAG) at King Chulalongkorn Memorial Hospital between January 2017 and March 2021 were retrospectively reviewed as a discovery cohort to identify factors discriminating patients with and without significant CAG-established CAD. HD patients receiving CAG between April 2021 and March 2023 were assigned as a validation cohort.
Read the detailed description
Background: Hemodialysis (HD) patients have increased cardiovascular risk. Coronary artery disease (CAD) may not typically manifest in these patients and the investigational results can be confounded by the fluctuation of body fluid and electrolytes. This study explored the accuracy of these findings in identifying CAD in HD patients.
Methods: Medical record data of all HD patients undergoing coronary angiography (CAG) at King Chulalongkorn Memorial Hospital between January 2017 and March 2021 were retrospectively reviewed as a discovery cohort to identify factors discriminating patients with and without significant CAG-established CAD. HD patients receiving CAG between April 2021 and March 2023 were assigned as a validation cohort.
- Keywords
- hemodialysis, coronary artery disease, electrocardiography, echocardiography, troponin, coronary angiography
- Medical subject headings
- Renal Insufficiency, Chronic, Coronary Artery Disease
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 |
|---|---|---|
| Positive coronary artery disease | Presence of significant coronary artery disease requiring intervention from a coronary angiography result | |
| Negative coronary artery disease | Absence of significant coronary artery disease requiring intervention from a coronary angiography result |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of coronary artery disease
Presence of significant coronary artery disease requiring intervention from a coronary angiography result
Measured: Any positive result between January 2017 and March 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Jan 2017
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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 HemodialysisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thana Thongsricome, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661941
- Sponsor's protocol ID
- 0042/65
- Acronym
- CAD in HD
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient confidential data
Publications
Go AS, Bansal N, Chandra M, Lathon PV, Fortmann SP, Iribarren C, Hsu CY, Hlatky MA; ADVANCE Study Investigators. Chronic kidney disease and risk for presenting with acute myocardial infarction versus stable exertional angina in adults with coronary heart disease. J Am Coll Cardiol. 2011 Oct 4;58(15):1600-7. doi: 10.1016/j.jacc.2011.07.010.
PubMed 21958887
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Tools for the Presence of Significant Coronary Artery Disease Requiring Intervention in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06661941
- Acronym / sponsor ID
- CAD in HD / 0042/65
- Keywords
- hemodialysis, coronary artery disease, electrocardiography, echocardiography, troponin, coronary angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 28 Oct 2024 (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.
Medical record data of all HD patients undergoing coronary angiography (CAG) at King Chulalongkorn Memorial Hospital between January 2017 and March 2021 were retrospectively reviewed as a discovery cohort to identify factors discriminating patients with and without significant CAG-established CAD. HD patients receiving CAG between April 2021 and March 2023 were assigned as a validation cohort.
Detailed description
Background: Hemodialysis (HD) patients have increased cardiovascular risk. Coronary artery disease (CAD) may not typically manifest in these patients and the investigational results can be confounded by the fluctuation of body fluid and electrolytes. This study explored the accuracy of these findings in identifying CAD in HD patients.
Methods: Medical record data of all HD patients undergoing coronary angiography (CAG) at King Chulalongkorn Memorial Hospital between January 2017 and March 2021 were retrospectively reviewed as a discovery cohort to identify factors discriminating patients with and without significant CAG-established CAD. HD patients receiving CAG between April 2021 and March 2023 were assigned as a validation cohort.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive coronary artery disease | – | –Presence of significant coronary artery disease requiring intervention from a coronary angiography result |
| Negative coronary artery disease | – | –Absence of significant coronary artery disease requiring intervention from a coronary angiography result |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult HD patients undergoing CAG at King Chulalongkorn Memorial Hospital of all indications between January 2017 and March 2021 with complete data
Key inclusion criteria (1 listed)
- All adult HD patients undergoing CAG at King Chulalongkorn Memorial Hospital of all indications between January 2017 and March 2021 with complete data
Key exclusion criteria (1 listed)
- Those resinged for using their clinical data for the research
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
Presence of coronary artery disease
Time frame: Any positive result between January 2017 and March 2023
Presence of significant coronary artery disease requiring intervention from a coronary angiography result
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 28 Oct 2024.
- Background: PubMed 21958887Go AS, Bansal N, Chandra M, Lathon PV, Fortmann SP, Iribarren C, Hsu CY, Hlatky MA; ADVANCE Study Investigators. Chronic kidney disease and risk for presenting with acute myocardial infarction versus stable exertional angina in adults with coronary heart disease. J Am Coll Cardiol. 2011 Oct 4;58(15):1600-7. doi: 10.1016/j.jacc.2011.07.010.
- Individual participant dataSharing planned: No. Patient confidential data
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemodialysis and Coronary Arterial Disease (CAD), run by Chulalongkorn University at 1 site in Thailand.
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: finished, as of the sponsor's last update on 28 Oct 2024. 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 Thailand. 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?
Presence of coronary artery disease (time frame: Any positive result between January 2017 and March 2023). 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 NCT06661941, 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 28 Oct 2024.