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Enrolling by invitation NCT07195968

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

— Observational Coronary Artery Disease

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: NTG-Pd/Pa measurement, Saline-Pd/Pa measurement.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 21 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 →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

1. To evaluate the numerical difference between NTG-Pd/Pa and saline-Pd/Pa. 2. To test the repeatability of saline-Pd/Pa. 3. 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.

Interventions

  • Diagnostic test NTG-Pd/Pa measurement
    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.
  • Diagnostic test Saline-Pd/Pa measurement
    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 outcome measures

  • Absolute difference between NTG-Pd/Pa and Saline-Pd/Pa value [Time frame: 3 minutes]
Secondary outcome measures (2)
  • Diagnostic performance of NTG-Pd/Pa and Saline-Pd/Pa [Time frame: 4 minutes]
  • Repeatability of Saline-Pd/Pa [Time frame: 2 minutes]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 3 centers
  • National Taiwan University Hospital Hsin-Chu Hospital — Hsinchu
  • Miaoli General Hospital, Ministry of Health and Welfare — Miaoli
  • Taichung Veterans General Hospital — Taichung

Identifiers

NCT: NCT07195968 · 202507242RINB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗