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Clinical Trials in India / NCT06602583
Starting soon Observational

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

NCT06602583 · tracked via the Priya Life Science India tracker
Sponsor
Dr Bharat Singh Sambyal
Phase
Observational
Started
2024-10-01
Last updated
2024-09-20

Condition(s) studied

Coronary Arterial Disease (CAD)

Investigational drug(s) / intervention(s)

Standard Dose Coronary angiographyNew low dose angiography

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.

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.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
INHS Asvini Mumbai Maharashtra
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06602583 on ClinicalTrials.gov ↗ ← All trials in India