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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Henry Ford Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00894179
First received: May 4, 2009
Last updated: June 21, 2011
Last verified: May 2010
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety and tolerability (using patient questionnaire) of REGAT stress echocardiography [ Time Frame: 1-7 days after stress test ] [ Designated as safety issue: Yes ]
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: May 2009
Estimated Study Completion Date: December 2011
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894179

Contacts
Contact: Karthikeyan Ananthasubramaniam, MD FACC 313-916-2721 kananth1@hfhs.org
Contact: Dee Dee Wang, MD 313-916-2721 DWANG2@hfhs.org

Locations
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Karthikeyan Ananthasubramaniam, MD    313-916-2721    kananth1@hfhs.org   
Contact: Dee Dee Wang, MD    313-916-2721    DWANG2@hfhs.org   
Principal Investigator: Karthikeyan Ananthasubramaniam, MD         
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Karthikeyan Ananthasubramaniam, MD FACC Henry Ford Hospital
  More Information

No publications provided

Responsible Party: Karthikeyan Ananthasubramaniam, Henry Ford Hospital
ClinicalTrials.gov Identifier: NCT00894179     History of Changes
Other Study ID Numbers: REGA-9B04
Study First Received: May 4, 2009
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014