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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.
• Диагностический тест 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.

Первичные конечные точки

• Absolute difference between NTG-Pd/Pa and Saline-Pd/Pa value [Срок оценки: 3 minutes]

Вторичные конечные точки (2)

• Diagnostic performance of NTG-Pd/Pa and Saline-Pd/Pa [Срок оценки: 4 minutes]
• Repeatability of Saline-Pd/Pa [Срок оценки: 2 minutes]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 3 центра

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

Идентификаторы

NCT: NCT07195968 · 202507242RINB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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