Predictive Tools for the Presence of Significant Coronary Artery Disease Requiring Intervention in Chronic Hemodialysis Patients (CAD in HD)

October 25, 2024 updated by: Thana Thongsricome, MD, Chulalongkorn University
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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • All adult HD patients undergoing CAG at King Chulalongkorn Memorial Hospital of all indications between January 2017 and March 2021 with complete data

Exclusion Criteria:

  • Those resinged for using their clinical data for the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Any positive result between January 2017 and March 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0042/65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient confidential data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe