Topics

Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)

2014-08-27 03:18:52 | BioPortfolio

Summary

The purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial SPECT-Imaging to detect defects in the supply of blood to the heart muscle (myocardial perfusion defects). The study will also look at whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.

Description

Adenosine is an effective vasodilator used in SPECT-Myocardial Perfusion Imaging (SPECT-MPI). However, it produces transient symptoms that are poorly tolerated by most subjects. PGxHealth has designed a multi-center, randomized crossover, double-blind study to compare the safety and effectiveness of apadenoson to adenosine (Adenoscan®) in SPECT-MPI. Subjects who are clinical candidates for SPECT-MPI will be enrolled to undergo two sequential SPECT-MPI studies. The first study will use adenosine as the stress agent in approximately 1300 subjects. Eligible subjects will then be randomized in a 1:2 assignment ratio to receive a second SPECT-MPI using either adenosine or apadenoson as the pharmacologic stress agent, with the goal of obtaining a total of 753 subjects who complete both studies. The similarity of the results from the two adenosine:adenosine stress tests will be compared to those from the adenosine:apadenosine tests to assess efficacy. The incidence and intensity of commonly reported side effects will be compared to evaluate improved tolerability.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Conditions

Coronary Artery Disease

Intervention

Apadenoson, Adenosine

Location

University of Alabama at Birmingham
Birmingham
Alabama
United States
35294

Status

Recruiting

Source

PGxHealth, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:52-0400

Clinical Trials [3542 Associated Clinical Trials listed on BioPortfolio]

Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

We are studying the affect of caffeine on the sensitivity of detecting coronary artery disease (blockages in the blood flow to the heart) with adenosine tracer scans. Adenosine is a drug u...

"Normal Coronary Artery" With Slow Flow Improved by Adenosine Injection, Dipyridamole Treatment and Clinical Follow-up

The investigators will investigate patients undergoing coronary angiography with normal coronary but slow blood flow that was normalized after adenosine injection into the coronary artery...

AMP as a Better Delivery System of Adenosine

Adenosine and AMP are substances normally present in the body. Adenosine is also given for the treatment of some heart rhythm problems and may be used to reduce heart damage during heart ...

Prophylactic Intra-Coronary Adenosine to Prevent Post Coronary Artery Stenting Myonecrosis

Myocardial damage occurs in up to 40% of cases when sensitive biomarkers are measured after coronary artery stenting. Such events have been associated with poor outcomes both at 30 days an...

Risk Factors of Individuals With Coronary Artery Disease

It would be useful to study coronary arteriovenous difference of various markers in patients who are undergoing coronary angiography for suspected coronary artery disease. Environmental an...

PubMed Articles [17377 Associated PubMed Articles listed on BioPortfolio]

NLRP3 is associated with coronary artery disease in Vietnam veterans.

Previous studies have established that coronary artery disease is associated with excess inflammation. These studies have shown an elevation of both pro and anti-inflammatory cytokines in sufferers of...

Multiple Coronary Artery Bypass Grafting for Kawasaki Disease-Associated Coronary Artery Disease.

Although coronary artery bypass grafting (CABG) is the preferred choice for advanced Kawasaki disease (KD)-associated coronary artery disease, graft design such as number of grafts or type of conduits...

Coronary artery calcium as a predictor of coronary heart disease, cardiovascular disease, and all-cause mortality in Asian-Americans: The Coronary Artery Calcium Consortium.

Coronary artery calcium (CAC) has been shown in multiple populations to predict atherosclerotic cardiovascular disease. However, its predictive value in Asian-Americans is poorly described.

'One for all' configuration: single left coronary artery with origin of the right coronary artery from the septal branch.

Coronary Bypass Versus Percutaneous Revascularization in Multivessel Coronary Artery Disease.

This study focused on contemporary outcomes after coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (MVCA...

Medical and Biotech [MESH] Definitions

Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.

Direct myocardial revascularization in which the internal mammary artery is anastomosed to the right coronary artery, circumflex artery, or anterior descending coronary artery. The internal mammary artery is the most frequent choice, especially for a single graft, for coronary artery bypass surgery.

A complication of INTERNAL MAMMARY-CORONARY ARTERY ANASTOMOSIS whereby an occlusion or stenosis of the proximal SUBCLAVIAN ARTERY causes a reversal of the blood flow away from the CORONARY CIRCULATION, through the grafted INTERNAL MAMMARY ARTERY (internal thoracic artery), and back to the distal subclavian distribution.

A congenital coronary vessel anomaly in which the left main CORONARY ARTERY originates from the PULMONARY ARTERY instead of from AORTA. The congenital heart defect typically results in coronary artery FISTULA; LEFT-SIDED HEART FAILURE and MITRAL VALVE INSUFFICIENCY during the first months of life.

Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.

More From BioPortfolio on "Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)"

Quick Search

Relevant Topics

Stress
Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Rheumatology
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...


Searches Linking to this Trial