Follow-up With CT-FFR in CHD Patients After DCB

Application of CT-derived Fractional Flow Reserve in Patients With Coronary Heart Disease After Drug-coated Balloon Intervention

In recent years, based on CCTA data, CT-derived fractional flow reserve (CT-FFR) developed by artificial intelligence and other technologies can provide both anatomical and functional information of coronary artery disease. Compared with CCTA alone, CT-FFR has a better ability to diagnose coronary ischemic lesions and can effectively reduce the need for unnecessary ICA, to predict revascularization more accurately.

Study Overview

• Status: Recruiting
• Conditions: Coronary; Ischemic
• Intervention / Treatment: Diagnostic test: CT-FFR

Detailed Description

Drug-coated balloon (DCB) intervention is a non-drug treatment of coronary heart disease with the advantage of "no implantation". In recent years, it is more and more used in primary coronary artery disease. Timely detection of restenosis after DCB is very important to ensure the safety of patients. Invasive coronary angiography (ICA) is the "gold standard" to reflect coronary artery stenosis, but it is difficult to become a routine follow-up tool for surgical trauma, radiation exposure and other reasons, let alone for elderly patients.

Coronary artery computed tomography angiography (CCTA) can provide a variety of anatomical information such as the degree of coronary artery stenosis and the nature of plaques. It is a commonly used tool for non-invasive imaging diagnosis of coronary heart disease. However, because of its low diagnostic specificity and can not reflect the lesion-related myocardial ischemia, the positive rate of coronary heart disease and the rate of revascularization in patients undergoing ICA are low. In recent years, based on CCTA data, CT-derived fractional flow reserve (CT-FFR) developed by artificial intelligence and other technologies can provide both anatomical and functional information of coronary artery disease. A number of studies have shown that, compared with CCTA alone, CT-FFR has a better ability to diagnose coronary ischemic lesions and can effectively reduce the need for unnecessary ICA, to predict revascularization more accurately. Due to the absence of metal foreign body implantation, DCB intervention makes it possible for CT-FFR to be used in imaging evaluation after DCB. At present, there is no study on the use of CT-FFR in patients after DCB.

In this study, the self-developed CT-FFR based on artificial intelligence was used for the first time to analyze coronary artery lesions in patients after DCB, and to compare the guiding value of CT-FFR and simple CCTA in ICA and revascularization, in order to provide an ideal non-invasive imaging follow-up tool for elderly patients after DCB.

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be able to understand the purpose of the test and sign the informed consent form.
2. 6-12 months after DCB for coronary heart disease, there is no contraindication of coronary artery CTA examination.
3. Non-target lesions of unplanned revascularization within 6 months.
4. According to the clinical manifestations and auxiliary examinations (such as EET, SPECT, CCTA), the attending doctor will make a comprehensive judgment on the patients who plan to undergo ICA.

Exclusion Criteria:

Patient exclusion criteria:

1. Previous coronary artery bypass (CABG) surgery, coronary artery stent implantation, artificial heart valve implantation, cardiac pacemaker or implantable defibrillator implantation.
2. Persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure (systolic blood pressure less than 90 mmHg), severe congestive heart failure (NYHA heart function III or IV) or acute pulmonary edema.
3. Acute myocardial infarction occurred within 7 days before selection.
4. Patients with other severe diseases are not suitable to participate in clinical trials, such as history of complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia or tachycardia, severe asthma, severe or extremely severe chronic obstructive pulmonary disease, chronic renal dysfunction (serum creatinine level > 2.0mg / dl or creatinine clearance < 30ml/ Kg ·1.73m2).
5. Allergic to iodinated contrast medium.
6. Other serious allergic diseases such as allergic asthma.
7. Pregnancy or pregnancy status unknown.
8. Life expectancy is less than 6 months.

9. There are any factors that other researchers think are not suitable for selection or completion of this study.

   -

CCTA image exclusion criteria:

1. Obvious dislocation of coronary artery image.
2. CCTA images indicate that the reference vessel diameter of the stenotic segment is less than 2.0mm.
3. The image of coronary artery calcification accounting for more than 80% of the cross-sectional area of the lumen.
4. The standard deviation of CT value (SD value) of aortic root image was higher than that of 30HU.
5. Coronary artery occlusion.
6. The CT-FFR measurement can not be completed due to the quality problem of the image file.
7. The clinical trial could not be completed and no effective data were obtained due to other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CT-FFR; The CCTA images of the patients in this group will be analyzed and the FFR values of the lesions will be measured using the indicated software. ICA will be determined according to the value of CTFFR.	Diagnostic test: CT-FFR; CCTA examination will be performed by qualified medical imaging technicians, and patients will be scanned with 256rows of CT, according to standard operating norms. The coronary artery physiological function evaluation software(Keya Medical Technology, Beijing, China)will be configured in the core laboratory in advance, and the relevant imaging analysts will be trained. The core laboratory will receive the CCTA inspection data and evaluate the CCTA image quality. According to the standard operation flow of the software specification, the CT-FFR analysis will be carried out on the images that meet the requirements, and the CT-FFR value of the lesions will be measured.
NO_INTERVENTION: direct ICA; The patients will be submitted to undergoing ICA procedure according to the decision of the investigators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of non-obstructive coronary heart disease in ICA examination	Proportion of non-obstructive coronary heart disease in ICA examination	Clinical follow-up at 6 months after ICA or CT-FFR

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of major adverse cardiac events (MACEs)	A composite endpoint of MACEs, including revascularization, non-fatal myocardial infarction, death and readmission for chest pain	Clinical follow-up at 6 months after ICA or CT-FFR

Collaborators and Investigators

• Sponsor: Beijing Hospital
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (ACTUAL): December 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: drug-coated balloon; CT-derived fractional flow reserve
• Other Study ID Numbers: CT-FFR after DCB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No