Coronary Artery Disease
Conditions
Keywords
coronary artery disease, stress echocardiography, regadenoson, atropine, coronary angiogram
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.
Interventions
DIAGNOSTIC_TESTregadenoson and atropine
Sponsors
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With REGAT Stress Echocardiography Protocol in the Detection of Significant Coronary Artery Disease. | within 7 days of the REGAT stress echocardiography | Patients undergoing REGAT (regadenoson +atropine) stress echocardiography were evaluated for wall motion abnormalities (ischemia) using REGAT stress echocardiography to predict \> 70% luminal stenosis |
| Sensitivity of Coronary Artery Territory | within 7 days of REGAT stress echocardiography | Sensitivity analysis of coronary artery territory using a 70% stenosis cutoff by angiography. |
| Specificity of Coronary Artery Territory | within 7 days of REGAT stress echocardiography | Specificity analysis on Coronary Artery Territory using a 70% stenosis cutoff by angiography. |
| Positive Predictive Value of Coronary Artery Territory | within 7 days of REGAT stress echocardiography | Analysis of positive predictive value of coronary artery territory using a 70% stenosis cutoff by angiography. |
| Negative Predictive Value of Coronary Artery Territory | within 7 days of REGAT stress echocardiography | Analysis of negative predictive value of coronary artery territory using a 70% stenosis cutoff by angiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Preferred the REGAT Stress Echocardiography Protocol Over Prior Stress Test | Following completion of REGAT stress echocardiography stress test | Patient post-procedure satisfaction survey administered immediately following the REGAT stress echocardiography protocol to assess tolerability and preference of REGAT stress echo protocol. The survey consisted of three questions in Likert format. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKarthikeyan Ananthasubramaniam, MD FACC
Henry Ford Hospital
Participant flow
Recruitment details
Between October 2009 and January 2012, out of 1596 outpatients referred for Coronary angiography we identified 54 patients meeting study criteria. Nine patients subsequently screen failed and hence we finally enrolled 45 patients into study.
Pre-assignment details
The first 10 patients were part of the run-in phase to test the safety of the combination of regadenoson and atropine and the request of the Food and Drug Administration. The first 10 patients did go on to complete the entire protocol and are included in the total of 45 patients. The study was prematurely terminated due to slow enrollment and poor recruitment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 45 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
None listed