GUARD-PH: Guided Use of AI-ECG for Risk Detection of PH in Surgery (GUARD-PH Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Artificial Intelligence-Enabled Electrocardiography System.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension (Diagnosis), Pre-operative Assessment, Postoperative Complications (Cardiopulmonary), Treatment Outcomes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- 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.]
Secondary outcome measures (4)
- Incidence of Surgical Complications [Time frame: 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).]
- Cardiovascular Mortality [Time frame: 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Taiwan · 1 center
- Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT07344207 · 2025-10-004CCF