Safety and Accuracy Study of Regadenoson Atropine Combination for Stress Echocardiography in Identification of Coronary Artery Disease (REGAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00894179
Recruitment Status : Unknown
Verified May 2010 by Henry Ford Health System.
Recruitment status was:  Recruiting
First Posted : May 6, 2009
Last Update Posted : June 23, 2011
Information provided by:
Henry Ford Health System

Brief Summary:

Purpose: The investigators plan to test a newly FDA approved pharmacologic stress agent, Regadenoson, in conjunction with atropine in the use of stress echocardiography for the diagnosis of coronary artery disease. The selective nature of Regadenoson allows for its use in patients with contraindications to the currently used drug, Adenosine, which is non-selective. Furthermore, the proposed protocol can be completed faster and without radiation exposure than the current protocol with adenosine.

Design: This is a prospective study evaluating people with no prior diagnosis of coronary disease with a prior stress test and are scheduled for cardiac catheterization. Patients who meet inclusion criteria will undergo regadenoson-atropine echocardiography protocol prior to their catheterization. The study will be interpreted by two independent readers blinded to the catheterization results. The sensitivity, specificity, positive and negative predictive values of the regadenoson-atropine study will be then be calculated using the coronary angiogram as a gold standard.

Condition or disease
Coronary Artery Disease

Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility, Safety and Accuracy of Regadenoson-Atropine ( REGAT) Stress Echocardiography for the Diagnosis of Coronary Artery Disease: An Angiographic Correlative Study
Study Start Date : May 2009
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Evaluate the sensitivity, specificity, positive and negative predictive value and accuracy of REGAT stress echocardiography protocol in the detection of coronary artery disease, using > 70% luminal stenosis on coronary angiogram as gold standard.

Secondary Outcome Measures :
  1. Evaluate the safety and tolerability (using patient questionnaire) of REGAT stress echocardiography [ Time Frame: 1-7 days after stress test ]
  2. Compare sensitivity, specificity, positive and negative predicative value and accuracy of a REGAT stress echocardiography protocol to other stress imaging modalities used in the patient cohort as per design of study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This will be a prospective study evaluating stable outpatients with no prior diagnosis of coronary disease who may or may not have had a prior functional stress imaging test and are going for a clinically indicated cardiac catheterization as deemed by their physician due to suspected coronary artery disease either based on symptoms or based on results for prior functional testing

Inclusion Criteria:

  1. Age > 18 years old
  2. Able to provide consent
  3. Scheduled for cardiac catheterization either with or without a prior functional stress imaging study

Exclusion Criteria:

  1. Any history of acute myocardial infarction, prior PCI in last 3 months, bypass surgery,
  2. History of greater than first degree AV block, sick sinus syndrome in patients
  3. Patients with a pacemaker/LBBB
  4. History on uncontrolled arrhythmias
  5. Patients with significant pulmonary disease, known or suspected bronchoconstrictive or bronchospastic lung disease or other hypersensitivity to adenosine
  6. History of cardiac transplantation, hypertrophic cardiomyopathy, acute myocarditis or pericarditis, severe valvular heart disease
  7. Hemodynamically unstable patients
  8. Dipyridamole use within 30 hours, consumption of methylxanthines (e.g., tea, coffee, caffeinated soft drinks, chocolate, or cocoa) within 12 hours, or use of sublingual nitroglycerin within 2 hours
  9. History of glaucoma or obstructive uropathy
  10. Allergy or hypersensitivity to atropine
  11. Participation in another investigational drug study within 1 month or participation in any previous regadenoson trial
  12. Pregnancy, breast feeding, or not using an acceptable method of birth control (if premenopausal)
  13. . History of end-stage renal disease on hemodialysis or peritoneal dialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00894179

Contact: Karthikeyan Ananthasubramaniam, MD FACC 313-916-2721
Contact: Dee Dee Wang, MD 313-916-2721

United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Karthikeyan Ananthasubramaniam, MD    313-916-2721   
Contact: Dee Dee Wang, MD    313-916-2721   
Principal Investigator: Karthikeyan Ananthasubramaniam, MD         
Sponsors and Collaborators
Henry Ford Health System
Principal Investigator: Karthikeyan Ananthasubramaniam, MD FACC Henry Ford Hospital

Responsible Party: Karthikeyan Ananthasubramaniam, Henry Ford Hospital Identifier: NCT00894179     History of Changes
Other Study ID Numbers: REGA-9B04
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: May 2010

Keywords provided by Henry Ford Health System:
coronary artery disease
stress echocardiography
coronary angiogram

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents