Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa (CANS)

NCT07195968 | Enrolling By Invitation FDA Drug FDA Device

• 1 other identifier: 202507242RINB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Fractional flow reserve; NTG-Pd/Pa; Saline-Pd/Pa

Outcome Measures

Primary Outcomes (1)

• 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.

  3 minutes

Secondary Outcomes (2)

• Diagnostic performance of NTG-Pd/Pa and Saline-Pd/Pa

  4 minutes

• Repeatability of Saline-Pd/Pa

  2 minutes

Other Outcomes (1)

• Target vessel failure

  3 years

Study Arms (1)

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.

Diagnostic Test: NTG-Pd/Pa measurement; Diagnostic Test: Saline-Pd/Pa measurement

Interventions

NTG-Pd/Pa measurement DIAGNOSTIC_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.

Cohort A

Saline-Pd/Pa measurement DIAGNOSTIC_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.

Cohort A

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Miaoli General Hospital, Ministry of Health and Welfare, Taiwan: collaborator
• Taichung Veterans General Hospital: collaborator

Study Sites (3)

National Taiwan University Hospital Hsin-Chu Hospital

Hsinchu, Select, 30047, Taiwan

Location

Miaoli General Hospital, Ministry of Health and Welfare

Miaoli, 36054, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Chien Boon Jong, MD

  National Taiwan University Hospital, Hsin-Chu Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 29, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)