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

NCT06602583 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-09-20

No results posted yet for this study

Summary

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

Conditions

  • Coronary Arterial Disease (CAD)

Interventions

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.

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.

Sponsors & Collaborators

  • Dr Bharat Singh Sambyal

    lead OTHER_GOV

Principal Investigators

  • Dr Bharat S Sambyal, DM Card · INHS Asvini

  • Dr R Anathakrishnan, DM Card · INHS Asvini

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-02-28
Completion
2025-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06602583 on ClinicalTrials.gov