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

NCT04664439 | Unknown

• 1 other identifier: CT-FFR after DCB
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary; Ischemic

Keywords

CT-derived fractional flow reserve; drug-coated balloon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The rate of major adverse cardiac events (MACEs)

  Clinical follow-up at 6 months after ICA or CT-FFR

Study Arms (2)

CT-FFR

EXPERIMENTAL

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

direct ICA

NO INTERVENTION

The patients will be submitted to undergoing ICA procedure according to the decision of the investigators.

Interventions

CT-FFR DIAGNOSTIC_TEST

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.

CT-FFR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to understand the purpose of the test and sign the informed consent form.
• months after DCB for coronary heart disease, there is no contraindication of coronary artery CTA examination.
• Non-target lesions of unplanned revascularization within 6 months.
• 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.

You may not qualify if:

• Previous coronary artery bypass (CABG) surgery, coronary artery stent implantation, artificial heart valve implantation, cardiac pacemaker or implantable defibrillator implantation.
• 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.
• Acute myocardial infarction occurred within 7 days before selection.
• 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).
• Allergic to iodinated contrast medium.
• Other serious allergic diseases such as allergic asthma.
• Pregnancy or pregnancy status unknown.
• Life expectancy is less than 6 months.
• There are any factors that other researchers think are not suitable for selection or completion of this study.
• Obvious dislocation of coronary artery image.
• CCTA images indicate that the reference vessel diameter of the stenotic segment is less than 2.0mm.
• The image of coronary artery calcification accounting for more than 80% of the cross-sectional area of the lumen.
• The standard deviation of CT value (SD value) of aortic root image was higher than that of 30HU.
• Coronary artery occlusion.
• The CT-FFR measurement can not be completed due to the quality problem of the image file.

Sponsors & Collaborators

• Beijing Hospital: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Peking Union Medical College: collaborator

Study Sites (1)

Beijing Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xue Yu, MD

  Beijing Hospital

  STUDY CHAIR

Central Study Contacts

Xue Yu, MD

CONTACT

00861085132266; yuxuemd@aliyun.com

Peng Li, MD

CONTACT

00861085132266; 185314206@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Cardiology Department

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: June 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

CN (1)