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

NCT07344207 | Not Yet Recruiting

• 1 other identifier: 2025-10-004CCF
• Study Type: interventional
• Target: 1,380
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Hypertension (Diagnosis); Pre-operative Assessment; Postoperative Complications (Cardiopulmonary); Treatment Outcomes

Keywords

Artificial Intelligence; Electrocardiography; AI-ECG; Preoperative Detection; Screening

Outcome Measures

Primary Outcomes (1)

• The incidence of newly diagnosed pulmonary hypertension or pulmonary hypertension-related cardiopulmonary diseases

  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 Outcomes (4)

• Incidence of Surgical Complications

  From the date of surgery up to 3 months post-operation.

• Length of Hospital Stay

  From admission until hospital discharge (assessed up to 3 months).

• Cardiovascular Mortality

  From the date of surgery up to 3 months post-operation.

• All-Cause Mortality

  From the date of surgery up to 3 months post-operation.

Study Arms (2)

AI-ECG Screening Group

EXPERIMENTAL

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

Standard of Care Group

NO INTERVENTION

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.

Interventions

Artificial Intelligence-Enabled Electrocardiography System DIAGNOSTIC_TEST

The intervention involves using an artificial intelligence-enabled electrocardiography system to analyze standard ECGs for the preoperative detection of pulmonary hypertension.

AI-ECG Screening Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Disease; Postoperative Complications

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yu-Feng Hu, M.D.

CONTACT

886-2-2871-2121; yfhu0609@nycu.edu.tw

Cheng-Hsueh Wu, M.D

CONTACT

886-2-2871-2121; chwu6@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 15, 2026
• Study Start: January 5, 2026
• Primary Completion: January 5, 2026
• Study Completion (Estimated): January 5, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)