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

National Taiwan University

Status: Invitation-only

Conditions: Coronary Artery Disease

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

Study type: Observational

Funder types: Other

Identifiers

NCT07195968

202507242RINB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Cohort A

Description:

Participants will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment.

Treatment:

Diagnostic Test: Saline-Pd/Pa measurement

Diagnostic Test: NTG-Pd/Pa measurement