To Determine the Difference in the Radiation Exposure, With Low Dose Protocols for Angiography (RADRED)

September 18, 2024 updated by: Dr Bharat Singh Sambyal

Radiation Exposure in Diagnostic Angiography With and Without a New Low Dose Exposure Protocol -Radiation Exposure Reduction Study

  1. The patients suspected coronary artery disease or those needing an angiography as per the inclusion criteria would be included after a 2d echocardiography and treadmill test/ stress myocardial stress imaging (if indicated) after a written and informed consent.
  2. Anthropometric and lab paraments would be recorded.

  3. Study will have 2 arms. I. A study arm 1 - baseline comparative arm of patients having undergone angiography with standard dose/ old low dose angiography.

    II. A study arm 2 - a comparative arm where the patients being once eligible for the study; would undergo angiography using the new low dose protocol.

  4. Post completion of the sample size the data of each angiographic view would be noted in both the study arms

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION

The increasing prevalence of cardiovascular diseases has led to a surge in the use of diagnostic angiography procedures. While these procedures are crucial for diagnosing and treating heart conditions, they also involve significant exposure to ionizing radiation. Excessive radiation exposure can pose serious health risks, including an increased risk of cancer and other adverse effects.

The RADRED study aims to address the critical issue of radiation exposure in cardiology catheterization labs. By comparing the radiation dose received by patients undergoing diagnostic angiography with and without a new low dose exposure protocol, the study seeks to evaluate the effectiveness of this protocol in reducing radiation exposure.

Several factors contribute to the need for such research. Firstly, the growing number of patients undergoing diagnostic angiography, particularly elderly individuals and those with multiple comorbidities, increases the cumulative radiation exposure to the population. Secondly, advancements in imaging technology have led to more complex procedures, often requiring longer fluoroscopy times, which can result in higher radiation doses. Finally, there is a growing awareness of the potential long-term health consequences of radiation exposure, particularly for vulnerable populations.

The RADRED study has the potential to make a significant contribution to the field of cardiology by demonstrating the feasibility and benefits of implementing a low dose exposure protocol in catheterization labs. By reducing radiation exposure, this protocol can help to protect the health of patients and healthcare providers, while also improving the overall efficiency and cost-effectiveness of diagnostic angiography procedures AIM To study determine the difference in the radiation exposure in diagnostic angiography with and without a new low dose exposure protocol

OBJECTIVES Primary objective To determine the difference in the radiation exposure levels received by patients undergoing diagnostic angiography with and without the new low dose exposure protocol.

Secondary objectives

  1. To evaluate the diagnostic image quality obtained with the new low dose exposure protocol compared to the standard protocol.
  2. To assess any potential limitations associated with the new low dose exposure protocol.

STUDY DESIGN:

Observational analytical cohort study

PARTICIPANTS:

Inclusion criteria:

Adult patients who qualify for a need of diagnostic angiography and are finally found to have normal epicardial coronaries, e.g.:

  • Pre aortic or mitral valve replacement angiography
  • TMT positive for inducible ischemia
  • SPECT MPI positive patients
  • Cradiologically symptomatic patients with ECG abnormalities, who cannot be subjected to stress test
  • High risk pre transplant patients

Exclusion criteria:

  • Those who are unwilling for study
  • Patients who come with STEMI or NSTEMI

STUDY METHOD:

  1. The patients suspected coronary artery disease or those needing an angiography as per the inclusion criteria would be included after a 2d echocardiography and treadmill test/ stress myocardial stress imaging (if indicated) after a written and informed consent.
  2. Anthropometric and lab paraments would be recorded.

  3. Study will have 2 arms. I. A study arm 1 - baseline comparative arm of patients having undergone angiography with standard dose/ old low dose angiography.

    II. A study arm 2 - a comparative arm where the patients being once eligible for the study; would undergo angiography using the new low dose protocol.

  4. Post completion of the sample size the data of each angiographic view would be noted in both the study arms

PERIOD OF STUDY: till completion of sample in study arm 2 (each successive patient would be enrolled - cluster sample)

PATIENT CONSENT:

Appropriate approval will be obtained from IEC of the institute.

STATISTCAL ANALYSIS Data will be compiled in an excel sheet for all the variables of interest and presented in the form of tables and graphs as appropriate.

Measures of central tendency (mean or median) would be calculated for all quantitative variables along with measures of dispersion (standard deviation or interquartile range). Qualitative or categorical variables will be described as frequencies and proportions. The investigators will use a t-test for independent samples to compare the means of radiation exposure All the statistical analysis will be carried out using Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, version 22.0 for Windows) at 5% level of significance i.e., p≤0.05 will be considered significant

ETHICAL JUSTIFICATION This study aims to evaluate the efficacy of a new low-dose radiation protocol for diagnostic angiography in cardiology Cath labs. By comparing patient radiation exposure with and without the protocol, the study seeks to reduce the cumulative radiation burden on patients, especially those at higher risk due to age or underlying health conditions. The increasing frequency of diagnostic angiography, coupled with advancements in imaging technology leading to more complex procedures, has resulted in a growing concern about the potential long-term health risks associated with radiation exposure. This study addresses this critical issue by exploring the effectiveness of a new protocol designed to minimize radiation dose during these procedures

. As, such low dose protocol has never been used earlier, there is a need for evaluating the same as to set new standards and protocols

The patients involved in the research project will be informed of the methods, anticipated benefits and potential risks of the study and the discomfort it may cause and the remedies thereof.

Written informed consent will be obtained. Every precaution will be taken to respect the privacy and confidentiality of the patient.

The parent has right to abstain from the study or to withdraw consent to participate at any time of the study without reprisal.

Due care and caution will be taken at all stages to ensure that the patient is put to minimum risk or suffer from irreversible side effects and probably benefit from study

DISCLOSURES/ CONFLICT OF INTEREST: NIL

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400005
        • INHS Asvini
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr Bharat S Sambyal, DM Card
        • Sub-Investigator:
          • Dr R Ananthakrishnan, DM Card

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing diagnostic angiography (age ≥18 years) will be included in the study.

Description

Inclusion Criteria:

Adult patients who qualify for a need of diagnostic angiography and are finally found to have normal epicardial coronaries, e.g.:

  • Pre aortic or mitral valve replacement angiography
  • TMT positive for inducible ischemia
  • SPECT MPI positive patients
  • Cradiologically symptomatic patients with ECG abnormalities, who cannot be subjected to stress test
  • High risk pre transplant patients

Exclusion Criteria:

  • Those who are unwilling for study
  • Patients who come with STEMI or NSTEMI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A study arm 1
baseline comparative arm of patients having already undergone angiography and fitting the inclusion criteria. The radiation exposure of this group would be collected from database of already done studies in the months prior to the initiation of the study (so as to prevent observer bias which may happen once the interventional cardiologist knows his inclusion in study, and may use a shorter or longer cine runs, thus influencing the outcomes). This would best represent the real-world data set, according to the routinely followed standard dose/ older low dose protocol.
Diagnostic test: Standard Dose Coronary angiography
The radiation exposure of this group would be collected from database of already done studies in the months prior to the initiation of the study (so as to prevent observer bias which may happen once the interventional cardiologist knows his inclusion in study, and may use a shorter or longer cine runs, thus influencing the outcomes). This would best represent the real-world data set, according to the routinely followed standard dose/ older low dose protocol.
Other Names:
  • Standard Dose Angiography
A study arm 2
a comparative arm where the patients being once eligible for the study; would undergo angiography using the new low dose protocol. A total of 5 to 8 different views (orthogonal) would be taken (2 for RCA and 4 to 6 for LAD/LCX)
Diagnostic test: New low dose angiography
a comparative arm where the patients being once eligible for the study; would undergo angiography using the new low dose protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the difference in the radiation exposure levels received by patients undergoing diagnostic angiography with and without the new low dose exposure protocol
Time Frame: Through study completion, and average of 06 monhts
Study aims to address the critical issue of radiation exposure in cardiology catheterization labs. By comparing the radiation dose received by patients undergoing diagnostic angiography with and without a new low dose exposure protocol, the study seeks to evaluate the effectiveness of this protocol in reducing radiation exposure.
Through study completion, and average of 06 monhts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Bharat Singh Sambyal

Investigators

  • Principal Investigator: Dr Bharat S Sambyal, DM Card, INHS Asvini
  • Study Director: Dr R Anathakrishnan, DM Card, INHS Asvini

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REF/2024/09/092182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Currently there is no plan to share the IPD data due to government hospital data sharing restrictions. though anonymous data can be shared with a fellow researcher if a combined study is planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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