NCT06498830

Brief Summary

This study (APPLE study) intends to retrospectively enroll more than 2000 patients who who underwent ≥2 coronary computed tomography angiography (CCTA) with ≥3 months interval from 11 hospitals in more than 4 provinces in China.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 12, 2024

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

July 6, 2024

Last Update Submit

July 6, 2024

Conditions

Computed Tomography AngiographyInflammation of Adipose TissueCFD

Outcome Measures

Primary Outcomes (1)

  • the formation and regression of any atherosclerotic plaque on the follow-up CCTA

    the formation and regression of any atherosclerotic plaque (Yes/No)

    1 day

Secondary Outcomes (1)

  • Total plaque volume

    1 day

Study Arms (2)

The formation of any atherosclerotic plaque on the follow-up CCTA

The regression of any atherosclerotic plaque on the follow-up CCTA

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent serial CCTA (at least 2 times) and enrolled those without plaque at baseline

You may qualify if:

  • patients underwent CCTAs at least twice;
  • patients without any concomitant obstructive CAD, or any concomitant atherosclerotic lesions in the LAD on the baseline CCTA;
  • patients without previous percutaneous coronary intervention or coronary artery bypass grafting, implanted cardiac devices, and anomalous coronary arteries as evidenced by conventional CCTA.

You may not qualify if:

  • image quality of CCTA was inadequate for either MB morphological or FAI or CFD analysis in either cardiac phase;
  • patients received other tube voltages except for 100 kVp and 120 kVp;
  • the interscan interval between serial CCTAs\< 3 months;
  • missing CCTA data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute Of Medical Imaging Jinling Hospital

Nanjing, Jiangsu, 210018, China

RECRUITING

MeSH Terms

Conditions

Steatitis

Condition Hierarchy (Ancestors)

Vitamin E DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesAnimal Diseases

Study Officials

  • Longjiang Zhang, MD

    Jinling Hospital, Medical School of Nanjing University, Nanjing, China

    STUDY CHAIR

Central Study Contacts

Longjiang Zhang, MD

CONTACT

+8613405833176kevinzhlj@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Radiology

Study Record Dates

First Submitted

July 6, 2024

First Posted

July 12, 2024

Study Start

October 17, 2023

Primary Completion

July 1, 2024

Study Completion

December 30, 2024

Last Updated

July 12, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)