Clinical trial NCT00894179: Safety and Accuracy Study of Regadenoson Atropine Combination for Stress Echocardiography in Identification of Coronary Artery Disease
Official title: Feasibility, Safety and Accuracy of Regadenoson-Atropine ( REGAT) Stress Echocardiography for the Diagnosis of Coronary Artery Disease: An Angiographic Correlative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
stress echocardiography
regadenoson
atropine
coronary angiogram
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: Evaluate the safety and tolerability (using patient questionnaire) of REGAT stress echocardiography
timeFrame: 1-7 days after stress test
measure: 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
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Karthikeyan Ananthasubramaniam, MD FACC
role: PRINCIPAL_INVESTIGATOR
References: