GUARD-PH: Guided Use of AI-ECG for Risk Detection of PH in Surgery (GUARD-PH Trial) (GUARD-PH)

January 7, 2026 updated by: Taipei Veterans General Hospital, Taiwan

A Prospective, Open-Label, Randomized Controlled Trial of an Artificial Intelligence Enabled Electrocardiography System for Preoperative Detection of Pulmonary Hypertension and Related Diseases(GUARD-PH)

This study is a prospective, open-label, randomized controlled trial designed to evaluate a new artificial intelligence (AI) tool for heart monitoring. Researchers will use an AI-enabled electrocardiography (ECG) system to screen patients before they undergo surgery. The main goal is to determine if this AI system can accurately detect pulmonary hypertension and related heart diseases in the preoperative setting. The study is being conducted at Taipei Veterans General Hospital.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, prospective, randomized controlled trial at Taipei Veterans General Hospital. Approximately 1,380 adult patients who already have a preoperative electrocardiogram (ECG) scheduled as part of routine care and have an established plan for elective surgery will be enrolled, along with approximately 30-60 participating physicians responsible for preoperative assessment and perioperative clinical care. The study evaluates whether integrating the Taiwan Medical Imaging Pulmonary Hypertension Detection System (TAIMedImg PHDS), an ECG-based clinical decision-support tool, during the preoperative preparation period can enable earlier identification of patients at risk of pulmonary hypertension and cardiopulmonary complications, and supports assessment of the potential cost-effectiveness of earlier risk recognition.

Patients are randomized to determine whether their responsible participating physician will receive TAIMedImg PHDS output derived from the patient's routine ECG. In the intervention arm, research staff upload the ECG to TAIMedImg PHDS and provide the analysis result to the participating physician; all other processes proceed as usual care. In the control arm, usual care proceeds without provision of TAIMedImg PHDS output. Randomization affects only access to this supplementary ECG-based output; it does not change patients' scheduled tests, clinical workflow, or rights to care. Clinical evaluation and management remain at the physician's discretion according to standard practice.

The study measures physicians' responses to ECG interpretation with versus without TAIMedImg PHDS output and documents the clinical decision-making trajectory, using routinely available medical record data for analysis. Results may inform improved preoperative pulmonary hypertension risk assessment and future perioperative care.

Study Type

Interventional

Enrollment (Estimated)

1380

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
        • Contact:

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

Description

Inclusion Criteria:

  1. Age between 18 and 80 years.
  2. Patients scheduled for non-cardiac surgery under general anesthesia.
  3. Patients who have a scheduled standard preoperative electrocardiogram (ECG).
  4. Patients capable of understanding the study and willing to provide medical records for research purposes, and who have signed the informed consent form.

Exclusion Criteria:

  1. Patients scheduled for emergency surgery.
  2. Patients who explicitly refuse to participate or withdraw consent.
  3. Patients with specific comorbidities that interfere with ECG interpretation or data collection (e.g., implanted pacemakers).

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-ECG Screening Group
The physician responsible for the participant in this arm will receive the results generated by the artificial intelligence-enabled electrocardiography (AI-ECG) system for pulmonary hypertension.
Diagnostic test: Artificial Intelligence-Enabled Electrocardiography System
The intervention involves using an artificial intelligence-enabled electrocardiography system to analyze standard ECGs for the preoperative detection of pulmonary hypertension.
No Intervention: Standard of Care Group
The physician responsible for the participant in this arm will not receive the results generated by the artificial intelligence-enabled electrocardiography (AI-ECG) system for pulmonary hypertension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of newly diagnosed pulmonary hypertension or pulmonary hypertension-related cardiopulmonary diseases
Time Frame: Before surgery, or within 90 days after electrocardiography in patients who did not undergo surgery.
The incidence of newly diagnosed pulmonary hypertension (defined as an echocardiographic right ventricular systolic pressure > 50 mmHg) or pulmonary hypertension-related cardiopulmonary diseases before surgery, or within 90 days after electrocardiography in patients who did not undergo surgery.
Before surgery, or within 90 days after electrocardiography in patients who did not undergo surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Surgical Complications
Time Frame: From the date of surgery up to 3 months post-operation.
Comparison of the incidence rates of surgical complications between the two groups.
From the date of surgery up to 3 months post-operation.
Length of Hospital Stay
Time Frame: From admission until hospital discharge (assessed up to 3 months).
Comparison of the total duration of hospitalization (in days) between the intervention and control groups.
From admission until hospital discharge (assessed up to 3 months).
Cardiovascular Mortality
Time Frame: From the date of surgery up to 3 months post-operation.
Evaluation of the rates of cardiovascular-related death between the two groups during the postoperative observation period.
From the date of surgery up to 3 months post-operation.
All-Cause Mortality
Time Frame: From the date of surgery up to 3 months post-operation.
Evaluation of the rates of all cause mortality between the two groups during the postoperative observation period.
From the date of surgery up to 3 months post-operation.

Collaborators and Investigators

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

Sponsor

Taipei Veterans General Hospital, Taiwan

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 (Estimated)

January 5, 2026

Primary Completion (Estimated)

January 5, 2026

Study Completion (Estimated)

January 5, 2027

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-10-004CCF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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