Application of a New X-ray Protective Device in Coronary Interventional Therapy

NCT05088291 | Completed

• 1 other identifier: 015
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, prospective and controlled clinical trial which will enroll 200 coronary arteriography or percutaneous coronary intervention with 2-4 interventional cardiologist. The interventional cardiologist performed 100 interventional procedures using either a new protective device (NPD) or a traditional lead clothing (TLC). The cumulative dose outside the NPD or TLC and the first operator at each height (110cm, 90cm, 50cm, 10cm) was measured. The main indicators of the study are the average X-ray shielding efficiency of the NPD and the TLC at four different heights. The investigators will record all operation information in this study.

Conditions

Coronary Heart Disease

Keywords

cardiology; coronary angiography; coronary angioplasty; percutaneous coronary intervention; radiation

Outcome Measures

Primary Outcomes (3)

• The cumulative absorbed dose at different heights outside the NPD

  The 16 thermoluminescent dosimetries (TLD) were placed outside the NPD at a height of 110cm, 90cm, 50cm and 10cm above the ground, with each height divided into four positions (front, back, left and right). After the test, the TLDs were sent to Jiangsu CDC for testing.

  After study completion, about 6 months

• The cumulative absorbed dose at different heights outside the TLC

  The 12 thermoluminescent dosimetries (TLD) were placed outside the NPD at a height of 110cm, 90cm and 50cm above the ground, with each height divided into four positions (front, back, left and right). After the test, the TLDs were sent to Jiangsu CDC for testing.

  After study completion, about 6 months

• The cumulative absorbed dose of the first operator

  The 16 thermoluminescent dosimetries (TLD) were placed at a height of 110cm, 90cm, 50cm and 10cm above the ground of the first operator (inside NPD or TLC), and each height is divided into four positions. After the test, the TLDs were sent to Jiangsu CDC for testing.

  After study completion, about 6 months

Study Arms (2)

The new protection device

A total of 100 patients underwent continuous coronary angiography (CAG) or percutaneous coronary intervention (PCI). The first surgeon does not need to wear a lead dress to stand inside the new protective device (NPD) to perform all operations.

The traditional lead clothing

A total of 100 patients underwent continuous coronary angiography (CAG) or percutaneous coronary intervention (PCI). The first surgeon wears the traditional lead clothing (TLC) to perform all operations.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for CAG or PCI were successively included in the First Affiliated Hospital of Nanjing Medical University and The First People's Hospital of Lianyungang.

You may qualify if:

• Consecutive patients were admitted to the group for coronary arteriography (CAG) or percutaneous coronary intervention (PCI).

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• The First People's Hospital of Lianyungang: collaborator

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Chunjian Li, Dr, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., MD, Ph.D, Director of CCU Ward

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 21, 2021
• Study Start: September 30, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

CN (1)