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Clinical Evaluation of Radiation Reduction for Optimized Safety
The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques.
Conditions:
🦠 Coronary Artery Disease 🦠 Myocardial Infarction 🦠 Coronary Disease 🦠 Coronary Stenosis 🦠 Angina Pectoris 🦠 Chest Pain
🗓️ Study Start (Actual) 15 June 2024
🗓️ Primary Completion (Estimated) 15 July 2024
✅ Study Completion (Estimated) 31 July 2024
👥 Enrollment (Estimated) 50
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Grand Rapids, Michigan, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Referred for clinically indicated coronary angiography
    • * ≥18 years of age
    • * Not pregnant
    • * English speaking
    • * Not imprisoned
    • * Able to provide written informed consent

    Exclusion Criteria:

    • * Hemodynamically or electrically unstable.
    • * Indication for coronary angiography is emergent, including ST-segment elevation myocardial infarction
    • * History of coronary artery bypass grafting
    • * An eGFR \<60
    • * Pregnant or lactating
    • * A BMI of 45 or greater
    • * Any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 March 2024
  • First Submitted that Met QC Criteria 31 March 2024
  • First Posted 5 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 March 2024
  • Last Update Posted 5 April 2024
  • Last Verified March 2024
I'm interested ...!!