Coronary Artery DiseaseNCT07195968
Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa (CANS)
An observational study of Coronary Artery Disease, run by National Taiwan University Hospital at 3 sites in Taiwan.
Trial summary
The goal of this observational study is to compare the value of NTG-Pd/Pa and saline-Pd/Pa in participants with intermediate stenosis of the coronary artery. The main questions it aims to answer are: The numerical difference between NTG-Pd/Pa and saline-Pd/Pa To compare the diagnostic performance of NTG-Pd/Pa and… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- NTG-Pd/Pa measurement and Saline-Pd/Pa measurement
- How many people
- 50 participants
- Where
- 3 sitesTaiwan
- Study dates
- 17 Sep 2025to 31 Dec 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants referred for coronary angiography with intermediate lesions will be invited to join the registry. Enrollment sites include medical facilities in northern and central Taiwan.
Who may be able to join
- Participants with coronary artery with 50-90% stenosis.
- In participants who suffered from ST elevation myocardial infarction within 5 days, only the non-culprit vessel was eligible for coronary functional testing.
Who cannot join
- Systolic blood pressure is less than 90 mmHg for more than 5 minutes during examination.
- Resting heart rate is less than 50 beats per minute.
- Heart failure remains decompensated at the time of examination, such as inability to lie flat or cardiogenic shock.
- Acute onset of asthma or chronic obstructive pulmonary disease.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites
National Taiwan University Hospital Hsin-Chu Hospital
Hsinchu, Select, 30047
Miaoli General Hospital, Ministry of Health and Welfare
Miaoli, 36054
Taichung Veterans General Hospital
Taichung, 407219
About this study
Official title: A Prospective, Multicenter Study: Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa
The goal of this observational study is to compare the value of NTG-Pd/Pa and saline-Pd/Pa in participants with intermediate stenosis of the coronary artery. The main questions it aims to answer are:
The numerical difference between NTG-Pd/Pa and saline-Pd/Pa To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment?
Participants will undergo NTG-Pd/Pa, Saline-Pd/Pa, and FFR successively in the target vessel.
Read the detailed description
Fractional Flow Reserve (FFR) is the gold standard for determining the functional ischemia of coronary arteries with intermediate lesions. Both intracoronary nitroglycerine (NTG) administration and saline administration induce an acute drop in trans-lesional coronary pressure. Both pressure ratios correlate well with FFR values and can reliably predict positive results in FFR assessments. The aims of this study were
- To evaluate the numerical difference between NTG-Pd/Pa and saline-Pd/Pa.
- To test the repeatability of saline-Pd/Pa.
- To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment.
Participants will be enrolled prospectively from National Taiwan University Hospital Hsinchu Hospital, Miaoli General Hospital, and Taichung Veterans General Hospital. The coronary artery with intermediate stenosis will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment.
- Conditions
- Coronary Artery Disease
- Being tested
- NTG-Pd/Pa measurement, Saline-Pd/Pa measurement
- Keywords
- Coronary artery disease, Fractional flow reserve, NTG-Pd/Pa, Saline-Pd/Pa
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTG-Pd/Pa measurementDiagnostic test
The coronary artery with intermediate stenosis will sequentially undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments. Intracoronary NTG dosage will follow the protocol based on blood pressure.
Saline-Pd/Pa measurementDiagnostic test
The coronary artery with intermediate stenosis will sequentially undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments. Ten millilitres of intracoronary saline will be given over five seconds.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Participants will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment. Receives: Diagnostic Test: NTG-Pd/Pa measurement; Diagnostic Test: Saline-Pd/Pa measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute difference between NTG-Pd/Pa and Saline-Pd/Pa value
The absolute difference was calculated as the Saline-Pd/Pa value minus the NTG-Pd/Pa value.
Measured: 3 minutes
Secondary outcomes (2)
Diagnostic performance of NTG-Pd/Pa and Saline-Pd/Pa
To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR≤0.80.
Measured: 4 minutes
Repeatability of Saline-Pd/Pa
Saline-Pd/Pa will be measured at one-minute intervals, and the absolute differences between consecutive measurements will be analyzed.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start17 Sep 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Miaoli General Hospital, Ministry of Health and Welfare, Taiwan, Taichung Veterans General Hospital
- Responsible party
- Sponsor
- Investigators
- Chien Boon Jong, MD, Study chair, National Taiwan University Hospital, Hsin-Chu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195968
- Sponsor's protocol ID
- 202507242RINB
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data cannot be shared publicly because of ethical restrictions. The restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are from the National Taiwan University Hospital Ethics Committee (contact via ntuhrec@ntuh.gov.tw) for researchers who meet the criteria for access to confidential data.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study: Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa
- ClinicalTrials.gov ID
- NCT07195968
- Acronym / sponsor ID
- 202507242RINB
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Fractional flow reserve, NTG-Pd/Pa, Saline-Pd/Pa
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Miaoli General Hospital, Ministry of Health and Welfare, Taiwan, Taichung Veterans General Hospital
- Study start
- 17 Sep 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Sep 2025 (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.
The goal of this observational study is to compare the value of NTG-Pd/Pa and saline-Pd/Pa in participants with intermediate stenosis of the coronary artery. The main questions it aims to answer are:
The numerical difference between NTG-Pd/Pa and saline-Pd/Pa To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment?
Participants will undergo NTG-Pd/Pa, Saline-Pd/Pa, and FFR successively in the target vessel.
Detailed description
Fractional Flow Reserve (FFR) is the gold standard for determining the functional ischemia of coronary arteries with intermediate lesions. Both intracoronary nitroglycerine (NTG) administration and saline administration induce an acute drop in trans-lesional coronary pressure. Both pressure ratios correlate well with FFR values and can reliably predict positive results in FFR assessments. The aims of this study were
- To evaluate the numerical difference between NTG-Pd/Pa and saline-Pd/Pa.
- To test the repeatability of saline-Pd/Pa.
- To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment.
Participants will be enrolled prospectively from National Taiwan University Hospital Hsinchu Hospital, Miaoli General Hospital, and Taichung Veterans General Hospital. The coronary artery with intermediate stenosis will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Diagnostic Test: NTG-Pd/Pa measurement, Diagnostic Test: Saline-Pd/Pa measurementParticipants will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants referred for coronary angiography with intermediate lesions will be invited to join the registry. Enrollment sites include medical facilities in northern and central Taiwan.
Key inclusion criteria (2 listed)
- Participants with coronary artery with 50-90% stenosis.
- In participants who suffered from ST elevation myocardial infarction within 5 days, only the non-culprit vessel was eligible for coronary functional testing.
Key exclusion criteria (4 listed)
- Systolic blood pressure is less than 90 mmHg for more than 5 minutes during examination.
- Resting heart rate is less than 50 beats per minute.
- Heart failure remains decompensated at the time of examination, such as inability to lie flat or cardiogenic shock.
- Acute onset of asthma or chronic obstructive pulmonary disease.
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 |
|---|---|---|
| NTG-Pd/Pa measurementThe coronary artery with intermediate stenosis will sequentially undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments. Intracoronary NTG dosage will follow the protocol based on blood pressure. | Diagnostic test | Cohort A |
| Saline-Pd/Pa measurementThe coronary artery with intermediate stenosis will sequentially undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments. Ten millilitres of intracoronary saline will be given over five seconds. | Diagnostic test | Cohort A |
Primary outcome
Absolute difference between NTG-Pd/Pa and Saline-Pd/Pa value
Time frame: 3 minutes
The absolute difference was calculated as the Saline-Pd/Pa value minus the NTG-Pd/Pa value.
2 secondary outcomes
Diagnostic performance of NTG-Pd/Pa and Saline-Pd/Pa
Time frame: 4 minutes
Repeatability of Saline-Pd/Pa
Time frame: 2 minutes
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 29 Sep 2025.
- Individual participant dataSharing planned: No. Data cannot be shared publicly because of ethical restrictions. The restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are from the National Taiwan University Hospital Ethics Committee (contact via ntuhrec@ntuh.gov.tw) for researchers who meet the criteria for access to confidential data.
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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.
Chien Boon Jong, MD study chair
National Taiwan University Hospital, Hsin-Chu Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by National Taiwan University Hospital at 3 sites 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute difference between NTG-Pd/Pa and Saline-Pd/Pa value (time frame: 3 minutes). 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 29 Sep 2025.