Quantitative Analysis of Functional CT Imaging of Coronary Atherosclerosis

NCT04986410 | Completed

• 1 other identifier: 2016YFC1300302
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a "one-stop" comprehensive coronary artery anatomy and function assessment for CAD.

Conditions

Coronary Artery Disease

Keywords

CT myocardial perfusion imaging; SPECT myocardial perfusion imaging

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events

  including cardiac death, all-cause death, acute coronary syndrome, readmission for acute coronary syndrome or heart failure, and Revascularization.

  5 years

Secondary Outcomes (4)

• Diagnostic performance of CT-MPI

  From admission to discharge, up to 1 week

• Diagnostic performance of CT-FFR

  From admission to discharge, up to 1 week

• Diagnostic performance of CT-MPI

  From admission to discharge, up to 1 week

• Diagnostic performance of CT-FFR

  From admission to discharge, up to 1 week

Study Arms (1)

Myocardial Perfusion examination

Diagnostic Test: CCTA, CT-MPI, CT-FFR, SPECT-MPI

Interventions

CCTA, CT-MPI, CT-FFR, SPECT-MPI DIAGNOSTIC_TEST

Subjects undergo CCTA, CT-MPI, CT-FFR or SPECT-MPI

Myocardial Perfusion examination

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected CAD

You may qualify if:

• Age ≥ 18 years
• Understand the purpose of the trial, voluntarily participate in this study, and have signed an informed consent form.
• Patients with known or suspected CAD

You may not qualify if:

• Patients with acute coronary syndrome.
• Severe cardiac dysfunction (LVEF ≤ 0.3).
• Cardiomyopathy with non-coronary causes such as hypertrophic cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy, and myocardial amyloidosis.
• Severe cardiac valve disease with more than moderate valvular regurgitation and/or valvular stenosis.
• Severe hepatic and renal dysfunction (ALT ≥ 3 Upper Limit of Normal, Cr\> 134μ/mol/L (2mg/dl) or estimated Glomerular Filtration Rate\<45ml/min/1.73m2).
• Severe arrhythmias (persistent atrial fibrillation, second-degree or third-degree atrioventricular block, etc.)
• Malignancy or other pathophysiological conditions with an expected survival of less than 1 year
• Allergic to the drug components involved in this study and those who are intolerant to loading tests
• Pregnant or lactating women.
• Mental disorders.
• Failure to sign the informed consent form.
• Other conditions that are incompatible with the clinical study.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mei Zhang

  Qilu Hospital of Shandong University

  STUDY CHAIR

• Mei Zhang

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: August 2, 2021
• Study Start: July 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)