PUMCH Study Into Individualized Scanning for Coronary Artery Disease

NCT05497466 | Unknown

• 1 other identifier: HS-2806 COE V1.3
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiac computed tomographic angiography (CCTA) is a non-invasive diagnostic imaging technique for visualization of the coronary arteries and thus, frequently used in the evaluation of coronary artery disease (CAD). CT technology is improving continuously, and various technological advances not only increase diagnostic accuracy, but also provide a substantial reduction in radiation dose and scan acquisition time. These modifications challenge optimal synchronization and timing of scan protocols in CM administration due to a shorter data acquisition window, hereby creating opportunities for injection strategies with a decrease in total amount of contrast media (CM). \[4-6\] Reducing the radiation dose of CT angiography and injected CM dose have become a routine need and trend in clinical practice. In addition to this, physical factors such as cardiac output and body weight are considered important factors with regard to variability in vascular enhancement. A standard 'one size fits all' protocol with a standard injected CM volume, independent of weight and length of the patient has proven to be outdated and precision medicine in the future should be based on individually tailored scan and CM injection protocols that are more scientific and involve various parameters such as individual tube voltage, patients weight and heart rate to benefit patients by reducing radiation exposure and CM dose while fulfilling the diagnostic purpose. Prospective studies focused on modifying both scan and injection parameters were completed in the Dutch (representing European) patient population with body weight varying between 40 and 130kg by Maastricht University Medical Center (MUMC) and have shown very promising results in Dutch population. In theory, these scan and injection protocols should be applicable to both average Dutch population (e.g. European population) and other heterogeneous patient populations, i.e. world-wide patient populations with any BMI category. However, so far, the effectiveness of this approach has not been deliberately discussed in the (on average) heavier North American population or the lighter Asian population. So, prior to promotion of the individually tailored CT scan protocols for global use, we need to obtain enough evidence in terms of the diagnostic confidence from those protocols in Chinese patients who could represent Asian population.

Conditions

Coronary Artery Disease; Coronary Computed Tomographic Angiography

Outcome Measures

Primary Outcomes (1)

• The diagnostic quality produced by individualized scan and injection protocol.

  When using an individualized scan and injection protocol, definition of diagnostic quality of the scan is the imaging result could satisfy the following two criteria： 1. Intravascular attenuation of the target coronary arteries should be over 325 Hounsfield Units (HU). 2. Subjective overall image quality should be diagnostic (image quality \> 2 of a 5-point Likert scale).

  48 hours post examination

Secondary Outcomes (11)

• Objective evaluation on image quality

  48 hours post examination

• Subjective evaluation on image quality

  48 hours post examination

• contrast media dose in ml

  During Injection procedure

• contrast media flow rate in ml/s

  During Injection procedure

• contrast media peak flow rate [ml/s]

  During Injection procedure

Study Arms (1)

Subjects who are male or female outpatients aged 18 years and scheduled for CCTA to rule out CAD

300 patients scheduled for coronary CTA examination to rule out CAD in PUMCH. Each subject will be selected and assigned in a specific tube-voltage arm by the scanner based on the patient's body habitus for individualized CTA scans, without any intervention

Eligibility Criteria

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

Study Population

The study aims to consecutively include 300 patients scheduled for coronary CTA examination to rule out CAD in PUMCH.

You may qualify if:

• Age: Patient aged older than 18;
• Deny previous cardiovascular history；
• Atypical or typical complaints of angina and referred for CCTA to rule out CAD with Iopromide 370 mgI/ml by clinicians
• Possibility of 'flash' mode scan: patient heart rate below 70 beats per minute and regular rhythm；
• Patients or families are able to understand the study protocol and willing to participate in the study and provide written informed consent.

You may not qualify if:

• Any contraindications for prospective ECG gate-control CT coronary angiography, including：
• Inability to perform a breath hold for at least the expected scan time；
• Unstable angina；
• Hemodynamic instability；
• Pregnant or lactating women；
• Renal insufficiency (defined as eGFR\<30 ml/min/1.73m2);
• Previous history of adverse reactions to iodinated contrast agents；
• Confirmed or suspected hyperthyroidism or pheochromocytoma；
• Atrial fibrillation or arrhythmia; severe congestive heart failure (class IV according to NYHA classification of cardiac function)；
• History of CAD
• Patients undergoing PCI before coronary CTA examination, or patients with a previous history of heart bypass surgery
• Insufficient cannula venous access (preferred 18G, minimal 20G cannula)；
• Patients who are participating other clinical studies。

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Bayer: collaborator

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

• Zhengyu Jin

  PUMCH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengyu Jin

CONTACT

+86 10 69159553; jinzy@pumch.cn

Yining Wang

CONTACT

+86 10 69159553; yiningpumc@163.com

Study Design

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

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 11, 2022
• Study Start: January 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 11, 2022

Record last verified: 2022-07