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Assessment of coronary atherosclerotic plaque stability using CT radiomic signature of pericoronary adipose tissue: study protocol for a prospective, single-center trial

Assessment of coronary atherosclerotic plaque stability using CT radiomic signature of pericoronary adipose tissue: study protocol for a prospective, single-center trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038644
Enrollment
Unknown
Registered
2020-09-26
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease

Interventions

Gold Standard:intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT)
Index test:A&#32
prediction&#32
model&#32
based&#32
on&#32
machine&#32
learning-derived&#32
model

Sponsors

General Hospital of Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Two kinds of patients will be enrolled in this study, consisting of patients with coronary artery disease (CAD) who undergo coronary artery bypass grafting (CABG) and patients with acute coronary syndrome (ACS) that undergo percutaneous coronary intervention (PCI). Detailed inclusion criteria are listed as follows: CABG group (patients meeting all of the following criteria will be enrolled) 1. Patients with CAD undergo coronary CT angiography (CCTA) within one week before CABG; 2. Aged 40 to 70 years; 3. Willingness to participate in and cooperate with clinical trials with a sufficient understanding of research methods and purposes. PCI group (patients meeting all of the following criteria will be enrolled): 1. Patients with ACS undergo endovascular imaging for detection of the culprit lesions during PCI; 2. Receiving CCTA within 72 hours after PCI; 3. Aged 40 to 70 years; 4. Willingness to participate in and cooperate with clinical trials with a sufficient understanding of research methods and purposes.

Exclusion criteria

Exclusion criteria: In this study, the exclusion criteria are available for both CABG group and PCI group ( patients meeting one or more of the following conditions will be excluded): 1. Patients undergoing cardiac surgery; 2. Patients with history of chest malignant tumor and/or related treatment history; 3. Patients with acute or chronic infectious diseases; 4. Patients with pericarditis or pericardial effusion; 5. Drug abusers; 6. Allergy history of iodine contrast medium; 7. The image quality of CCTA is poor and the artifacts are serious; 8. Abnormal origin of coronary artery or single coronary artery malformation.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of the patch stability prediction model using test set data;

Secondary

MeasureTime frame
The diagnostic accuracy, area under the ROC curve, cut-off value, positive predictive value and negative predictive value of the patch stability prediction model using test set data;

Countries

China

Contacts

Public ContactBenqiang Yang

General Hospital of Northern Theater Command

bqyang888@sina.com+86 13309886610

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026