Coronary Imaging and Metabolic Indicators-Based Risk Prediction Model for Coronary Artery Disease(CMI-RiskCAD)

NCT07353762 | Not Yet Recruiting

• 1 other identifier: BeijingAnzhen_2
• Study Type: observational
• Target: 10,960
• Locations: 1 country
• Sites: 1

Brief Summary

The primary design of this study is an ambispective cohort study. We plan to integrate coronary imaging features (including parameters derived from Coronary Computed Tomography Angiography(CCTA) and coronary angiography(CAG)), coronary functional indices (e.g., FFR, QFR), and metabolic biomarkers (e.g., LDL-C, Lp(a), hs-CRP). First, we will develop a multimodal risk prediction model for coronary artery disease using a retrospective cohort; subsequently, we will validate the model in a prospective cohort to assess its performance in discriminating high- versus low-risk individuals and to explore its potential clinical utility for risk stratification and decision-making.

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Keywords

Coronary Computed Tomography Angiography; Perivascular Fat Attenuation Index; Coronary Angiography-derived FFR

Outcome Measures

Primary Outcomes (10)

• The composite endpoint of major adverse cardiovascular events (MACE)

  including cardiac death, non-fatal myocardial infarction, and rehospitalization for unstable angina or heart failure.

  At 12, 24, 36, 48, and 60 months after discharge

• Frequency of occurrence of high-risk plaques

  Frequency (%) of occurrence of high-risk plaque morphologic features (ow-attenuation plaques, positive remodeling, spotty calcification, and the napkin-ring sign, minimal lumen area\[MLA\]\<4mm2)

  baseline, pre-intervention

• CT Fractional Flow Reserve gradient

  The CT-FFR gradient is defined as the peak instantaneous CT-FFR gradient per unit vessel length, serving as an indicator of local lesion severity. The calculation of the CT-FFR gradient was performed only for lesions with diameter stenosis \> 30%.

  baseline, pre-intervention

• Perivascular Fat Attenuation Index

  The Fat Attenuation Index (FAI) was defined as the mean attenuation of perivascular adipose tissue (PVAT). The density range of adipose tissue included in the analysis was restricted to -190 HU to -30 HU, and the FAI surrounding the target vessel was automatically calculated by the software.

  baseline, pre-intervention

• PPG derived by follow up CCTA

  pullback pressure gradient (PPG) derived by follow up CCTA, the values derived from CT-FFR were calculated using the formula

  baseline, pre-intervention

• SYNTAX score

  In patients undergoing coronary angiography, each lesion (diameter stenosis ≥ 50%) within the coronary artery tree was quantified based on the angiographic findings

  immediately after the intervention

• Coronary Angiography-derived FFR and Coronary Angiography-derived Index of Microcirculatory Resistance

  In patients undergoing coronary angiography, clear angiographic images of the left anterior descending (LAD), left circumflex (LCX), and right coronary arteries (RCA) were acquired from at least two different projections, ensuring no overlap or foreshortening. Three-dimensional (3D) reconstruction and hemodynamic calculations were performed using dedicated software (AccuIMR version 1.0).

  baseline, pre-intervention

• Radial Wall Strain

  For patients undergoing coronary angiography, image frames corresponding to four key cardiac phases-late systole, early systole, late systole, and mid-diastole-were selected for a specific vessel. After segmentation and registration of the lumen contours

  immediately after the intervention

• IVUS-related parameters

  Minimal Lumen Area, Minimal Lumen Diameter

  immediately after the intervention

• OCT-related parameters

  Minimal Lumen Area, Lipid Core Burden Index, Fibrous Cap Thickness

  immediately after the intervention

Study Arms (2)

retrospective cohort

patients with suspected CAD who underwent CCTA between 2020 and 2025

prospective cohort

patients with suspected CAD who underwent CCTA between 2026 and 2030

Eligibility Criteria

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

Study Population

Suspected CAD patients underwent CCTA

You may qualify if:

• (1)Completion of CCTA examination. (2)Age ≥ 18 years. (3)Signed written informed consent, and willing and able to comply with baseline assessment and long-term follow-up.

You may not qualify if:

• Acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) occurring within 72 hours; history of coronary artery bypass grafting (CABG); severe valvular heart disease; dilated or hypertrophic cardiomyopathy; congenital heart disease; or heart failure (NYHA functional class III-IV).
• Severe hepatic insufficiency (Child-Pugh class C) or renal failure (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73m²).
• Pregnancy or lactation.
• Life expectancy of less than 1 year, or any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in the study.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Related Publications (1)

• Nurmohamed NS, Min JK, Anthopolos R, Reynolds HR, Earls JP, Crabtree T, Mancini GBJ, Leipsic J, Budoff MJ, Hague CJ, O'Brien SM, Stone GW, Berger JS, Donnino R, Sidhu MS, Newman JD, Boden WE, Chaitman BR, Stone PH, Bangalore S, Spertus JA, Mark DB, Shaw LJ, Hochman JS, Maron DJ. Atherosclerosis quantification and cardiovascular risk: the ISCHEMIA trial. Eur Heart J. 2024 Sep 29;45(36):3735-3747. doi: 10.1093/eurheartj/ehae471.

  PMID: 39101625 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Two 10-mL EDTA tubes were collected and centrifuged at 4°C for plasma separation

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Central Study Contacts

Chenchen Tu

CONTACT

+8615201648899; tcc2033@mail.ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)