Status:
UNKNOWN
A Low-dose Radiation and Contrast Agent Exposure Protocol for Coronary CTA in Diabetic Patients
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Collaborating Sponsors:
Yangtze River Pharmaceutical Group Co., Ltd.
Fudan University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To assess diagnostic accuracy,image quality and renal safety of a double low-dose coronary CTA protocol at coronary artery evaluation in patients with diabetes by using invasive coronary angiography(I...
Detailed Description
The study has been approved by the local ethics committee and allparticipants will be provided written informed consent. Iodixanol 320 mg/ml is injected followed by 30 ml of saline solution.In the tes...
Eligibility Criteria
Inclusion
- age ≥ 18 years old and ≤ 80 years old;
- patients who have previously diagnosed diabetes;
- patients with suspected coronary artery disease and undergoing coronary CT angiography (CTA);
- Subjects are fully informed and provided written informed consent.
Exclusion
- The exclusion criteria are pregnancy and lactation women or recent birth planners
- patients with Iodine contrast agent contraindications (such as a history of severe allergy history with iodine contrast agents, hyperthyroidism, etc.)
- patients with chronic kidney disease (Phase 4-5, eGFR \<30 ml/min/1.73 m2)
- patients who have undergone coronary stent implantation or coronary artery bypass surgery
- patients who have received iodine contrast-related tests within 24 hours
- participated in other clinical trials within 3 months
- other circumstances that the investigator believes are not suitable for participation in the trial
Key Trial Info
Start Date :
October 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04342455
Start Date
October 7 2018
End Date
December 31 2020
Last Update
April 13 2020
Active Locations (1)
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1
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China