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Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress

NCT01370265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-09-05

Study results available
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Summary

Blockage of the heart arteries (coronary artery disease) can lead to angina (chest pain), heart attacks, heart failure, and/or death. Positron emission tomography (PET) stress myocardial perfusion imaging (MPI) is a powerful tool to help identify blockages in the coronary arteries. During the PET MPI test, a drug is given to mimic the effects of exercise on the heart. The study was done to measure blood flow to the heart using two similar drugs approved to mimic the effects of exercise on the heart in people during a heart stress test. The first drug, called adenosine, has been approved for this use for several decades. The second drug, called regadenoson, was approved in 2008. The investigators were looking at whether the increase in blood flow to the heart with the newer drug (regadenoson) was similar to the increase in blood flow with the older drug (adenosine). This information is important for the use of these drugs in patients and for interpreting the blood flow values.

Conditions

Interventions

DRUG

Regadenoson

Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush.

DRUG

Adenosine

Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes.

DRUG

N-13 ammonia

Ammonia N-13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. The N-13 ammonia used in the study was synthesized by the Mayo Cyclotron Facility as per routine institutional clinical protocol.

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Panithaya Chareonthaitawee, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-02-29
Completion
2012-06-30

Countries

  • United States

Study Locations

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Diseases
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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 NCT01370265 on ClinicalTrials.gov