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NCT Number: NCT07195968

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital Hsin-Chu Hospital, Hsinchu, Select, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Diagnostic performance of NTG-Pd/Pa and Saline-Pd/Pa

    Time frame: 4 minutes

    To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR≤0.80.

  2. Repeatability of Saline-Pd/Pa

    Time frame: 2 minutes

    Saline-Pd/Pa will be measured at one-minute intervals, and the absolute differences between consecutive measurements will be analyzed.

Other outcomes

  1. Target vessel failure

    Time frame: 3 years

    The target vessel failure included target vessel myocardial infarction, target vessel restenosis or revascularization.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Miaoli General Hospital, Ministry of Health and Welfare, Taiwan
  • Taichung Veterans General Hospital

Registry information

Official study title

A Prospective, Multicenter Study: Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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