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

May 4, 2009
June 21, 2011
May 2009
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00894179 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Accuracy Study of Regadenoson Atropine Combination for Stress Echocardiography in Identification of Coronary Artery Disease
Feasibility, Safety and Accuracy of Regadenoson-Atropine ( REGAT) Stress Echocardiography for the Diagnosis of Coronary Artery Disease: An Angiographic Correlative Study

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

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

Coronary Artery Disease
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
December 2011
Not Provided

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
Both
18 Years to 85 Years
No
Contact: Karthikeyan Ananthasubramaniam, MD FACC 313-916-2721 kananth1@hfhs.org
Contact: Dee Dee Wang, MD 313-916-2721 DWANG2@hfhs.org
United States
 
NCT00894179
REGA-9B04
No
Karthikeyan Ananthasubramaniam, Henry Ford Hospital
Henry Ford Health System
Not Provided
Principal Investigator: Karthikeyan Ananthasubramaniam, MD FACC Henry Ford Hospital
Henry Ford Health System
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP