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

NCT01370265 | Completed Results

• 1 other identifier: 10-006377
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease

Keywords

Regadenoson (Lexiscan); PET N-13 ammonia imaging; Myocardial Blood Flow (MBF); Regadenoson Stress

Outcome Measures

Primary Outcomes (1)

• Global Hyperemic Myocardial Blood Flow (MBF)

  MBF is the rate of blood supplied to the myocardium, or heart muscle. Hyperemic MBF is the rate of myocardial blood flow in the heart muscle during either regadenoson or adenosine stress. Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4). The Hyperemic MBF was measured approximately 4 hours after arrival in the PET unit.

  Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit

Secondary Outcomes (6)

• Resting Global MBF and Resting Segmental MBF

  Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit

• Global Cardiac Flow Rate

  Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit

• Hyperemic Segmental MBF

  Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit

• Segmental CFR

  Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit

• Heart Rate (Beats Per Minute (BPM))

  Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit

Study Arms (2)

Regadenoson, then Adenosine

ACTIVE COMPARATOR

Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the first intervention period. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the second intervention period (after washout period). Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.

Drug: Regadenoson; Drug: Adenosine; Drug: N-13 ammonia

Adenosine, then Regadenoson

ACTIVE COMPARATOR

Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the first intervention period. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. After a washout period, Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the second intervention period.

Drug: Regadenoson; Drug: Adenosine; Drug: N-13 ammonia

Interventions

Regadenoson DRUG

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

Also known as: Lexiscan

Adenosine, then Regadenoson; Regadenoson, then Adenosine

Adenosine DRUG

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

Also known as: Adenoscan

Adenosine, then Regadenoson; Regadenoson, then Adenosine

N-13 ammonia DRUG

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.

Adenosine, then Regadenoson; Regadenoson, then Adenosine

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female volunteers over the age of 30.
• Written informed consent will be obtained from each subject.
• Each subject will undergo a history and physical examination

You may not qualify if:

• Any cardiovascular or pulmonary symptoms or exam findings
• History of low blood pressure (\< 90/50 mmHg)
• Prior cardiac history
• History of hypertension
• History of hyperlipidemia
• History of diabetes mellitus
• History of asthma or chronic obstructive pulmonary disease
• Weight of \> 450 pounds
• Chronic kidney disease
• Other serious illness such as cancer
• Current smoking
• Medication use (with the exception of acetaminophen, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), and thyroid hormone replacement)
• Illicit drug use
• Prior allergic reaction to adenosine, regadenoson, or aminophylline
• Pregnancy

Sponsors & Collaborators

• Mayo Clinic: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

regadenoson; Adenosine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

Small sample size; Subjects had no evidence of overt coronary artery disease, occult coronary artery disease affecting stress drug induced hyperemic PET MBF is a possibility; however, hyperemic MBF with both stress drugs would be equally affected.

Results Point of Contact

• Title: Dr. Panithaya Chareonthaitawee
• Organization: Mayo Clinic

chareonthaitawee.panithaya@mayo.edu

507-284-1648

Study Officials

• Panithaya Chareonthaitawee, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Associate Professor

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 9, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 5, 2013
• Results First Posted: September 5, 2013

Record last verified: 2013-09

Locations

US (1)