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

NCT06602583 | Not Yet Recruiting DMC

• 1 other identifier: REF/2024/09/092182
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Anthropometric and lab paraments would be recorded.
3. 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.
4. 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)

Keywords

coronary angiography; coronary artery disease; radiation exposure; DAP; KAP

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

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

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

Interventions

Standard Dose Coronary angiography DIAGNOSTIC_TEST

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.

Also known as: Standard Dose Angiography

A study arm 1

New low dose angiography DIAGNOSTIC_TEST

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

A study arm 2

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dr Bharat Singh Sambyal: lead

Study Sites (1)

INHS Asvini

Mumbai, Maharashtra, 400005, India

Location

Related Publications (5)

• Picano E. Sustainability of medical imaging. BMJ. 2004 Mar 6;328(7439):578-80. doi: 10.1136/bmj.328.7439.578.

  PMID: 15001510 BACKGROUND

• Padovani R, Le Heron J, Cruz-Suarez R, Duran A, Lefaure C, Miller DL, Sim HK, Vano E, Rehani M, Czarwinski R. International project on individual monitoring and radiation exposure levels in interventional cardiology. Radiat Prot Dosimetry. 2011 Mar;144(1-4):437-41. doi: 10.1093/rpd/ncq326. Epub 2010 Nov 3.

  PMID: 21051431 BACKGROUND

• Stocker TJ, Abdel-Wahab M, Mollmann H, Deseive S, Massberg S, Hausleiter J. Radiation Dose in Diagnostic Cardiac Catheterization: Results From the PROTECTION VII Study. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1958-1960. doi: 10.1016/j.jcin.2021.07.023. No abstract available.

  PMID: 34503751 BACKGROUND

• Tong J, Hei TK. Aging and age-related health effects of ionizing radiation. Radiat Med Prot [Internet]. 2020 Mar 1 [cited 2024 Sep 10];1(1):15-23. Available from: https://www.sciencedirect.com/science/article/pii/S2666555720300058

  BACKGROUND

• Kar S, Teleb M, Albaghdadi A, Ibrahim A, Mukherjee D. Efficacy of Low-Dose Compared With Standard-Dose Radiation for Cardiac Catheterization and Intervention (KAR RAD Study). J Invasive Cardiol. 2019 Jun;31(6):187-194. doi: 10.25270/jic/18.00332. Epub 2019 Mar 15.

  PMID: 30865914 BACKGROUND

Related Links

• Radiation Units and Conversion Factors - Radiation Emergency Medical Management \[Internet\]. \[cited 2024 Sep 10\].

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Angiography; Angiography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests

Study Officials

• Dr Bharat S Sambyal, DM Card

  INHS Asvini

  PRINCIPAL INVESTIGATOR

• Dr R Anathakrishnan, DM Card

  INHS Asvini

  STUDY DIRECTOR

Central Study Contacts

Dr Bharat S Sambyal, DM Card

CONTACT

+91 838 403 1327; drbharatsambyal@gmail.com

Dr R Anathakrishnan, DM Card

CONTACT

+91 750 611 1334; anantha25@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: April 30, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

IN (1)