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Randomized trial to study the effect of ursodeoxycholic acid versus placebo in interpretation of myocardial perfusion scintigraphy

Randomized double blind placebo controlled parallel trial to study the effect of ursodeoxycholic acid versus placebo in facilitating early hepatic clearance of radiotracer among patients undergoing 99mTc-sestamibi myocardial perfusion scintigraphy for detection of myocardial ischemia/ viability - UDCAMPS

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009506
Enrollment
120
Registered
2017-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I258- Other forms of chronic ischemic heart disease

Interventions

Intervention1: Ursodeoxycholic acid: 300 mg two tablets to be taken with meal for 3 days Control Intervention1: Identical placebo: Identical looking placebo to be taken with meal for 3 days

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: known or suspected coronary artery disease patients

Exclusion criteria

Exclusion criteria: 1. Less than 18 years 2.Patient not willing to give the consent 3.Any patient with contraindication to use UDCA as interventional drug eg. gall stone disease, gall bladder inflammation, biliary tract occlusion, biliary colic and hypersenstivity to the drug etc. 4.Patient with hepatic disorder affecting the tracer uptake 5.Pregnant and lactating female patients

Design outcomes

Primary

MeasureTime frame
(1) Interpretability of the MPS scan at 30 minutes and 60 minutes of the study in both the groups (case & control). (2) Percentage reduction in the liver tracer activity at 60 minutes as compared to 30 minutes in both the groups. (3) Myocardial to liver tracer activity ratio at 30 minutes & 60 minutes in both the groups.Timepoint: During MPS procedure

Secondary

MeasureTime frame
To facilitate early imaging in patients undergoing MPSTimepoint: During MPS procedure

Countries

India

Contacts

Public ContactProf B R Mittal

PGIMER

ushadutta@gmail.com8198877022

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026