Pulmonary Hypertension (Diagnosis)GUARD-PHNCT07344207
GUARD-PH: Guided Use of AI-ECG for Risk Detection of PH in Surgery (GUARD-PH Trial)
A study testing Artificial Intelligence-Enabled Electrocardiography System in people with Pulmonary Hypertension (Diagnosis) and Pre-operative Assessment, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension (Diagnosis), Pre-operative Assessment, Postoperative Complications (Cardiopulmonary)
- What is being tested?
- Artificial Intelligence-Enabled Electrocardiography System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,380 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jan 2026to 5 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Veterans General Hospital
Taipei
Yu-Feng Hu, M.D., 886-2-2871-2121, yfhu0609@nycu.edu.tw
About this study
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)
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.
Read the 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.
- Conditions
- Pulmonary Hypertension (Diagnosis), Pre-operative Assessment, Postoperative Complications (Cardiopulmonary), Treatment Outcomes
- Being tested
- Artificial Intelligence-Enabled Electrocardiography System
- Keywords
- Artificial Intelligence, Electrocardiography, AI-ECG, Preoperative Detection, Screening
- Medical subject headings
- Hypertension, Pulmonary, Disease, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-Enabled Electrocardiography SystemDiagnostic test
The intervention involves using an artificial intelligence-enabled electrocardiography system to analyze standard ECGs for the preoperative detection of pulmonary hypertension.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgery, or within 90 days after electrocardiography in patients who did not undergo surgery.
Secondary outcomes (4)
Incidence of Surgical Complications
Comparison of the incidence rates of surgical complications between the two groups.
Measured: From the date of surgery up to 3 months post-operation.
Length of Hospital Stay
Comparison of the total duration of hospitalization (in days) between the intervention and control groups.
Measured: From admission until hospital discharge (assessed up to 3 months).
Cardiovascular Mortality
Evaluation of the rates of cardiovascular-related death between the two groups during the postoperative observation period.
Measured: From the date of surgery up to 3 months post-operation.
All-Cause Mortality
Evaluation of the rates of all cause mortality between the two groups during the postoperative observation period.
Measured: From the date of surgery up to 3 months post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start5 Jan 2026 (estimated)
- Primary completion5 Jan 2026 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344207
- Sponsor's protocol ID
- 2025-10-004CCF
- Acronym
- GUARD-PH
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07344207
- Acronym / sponsor ID
- GUARD-PH / 2025-10-004CCF
- Conditions
- Pulmonary Hypertension (Diagnosis), Pre-operative Assessment, Postoperative Complications (Cardiopulmonary), Treatment Outcomes
- Keywords
- Artificial Intelligence, Electrocardiography, AI-ECG, Preoperative Detection, Screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,380 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 5 Jan 2026 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 15 Jan 2026 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-ECG Screening Group | Experimental | Diagnostic Test: Artificial Intelligence-Enabled Electrocardiography SystemThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Intelligence-Enabled Electrocardiography SystemThe intervention involves using an artificial intelligence-enabled electrocardiography system to analyze standard ECGs for the preoperative detection of pulmonary hypertension. | Diagnostic test | AI-ECG Screening Group |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-Enabled Electrocardiography System in people with Pulmonary Hypertension (Diagnosis) and Pre-operative Assessment, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 Jan 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Feng Hu, M.D. (886-2-2871-2121 ext. #1262, yfhu0609@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.