Suspected coronary artery disease MedDRA version: 9.1 Level: LLT Classification code 10011078 Term: Coronary artery disease
Conditions
Interventions
Product Name: Regadenoson
Product Code: CVT-3146
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Regadenoson
CAS Number: 875148-45-1
Current Sponsor code: CVT-3146
Concentration unit:
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females = 18 years of age. 2. For Groups A, B, B-1 and C: Had a clinically indicated dobutamine stress echocardiogram (without contraindications for receiving dobutamine) with the following results: a) Adequate image quality with 4 or more segments evaluable in each view (apical 4-chamber, apical 3-chamber, apical 2-chamber and parasternal short-axis view at the papillary muscle level) b) Definitively normal images (i.e. uniformly normal wall excursion and wall thickening) at rest and definitive reversible wall motion abnormalities during stress (Hypokinesia - reduced inward systolic wall motion; Akinesia - absence of both inward motion and of thickening; Dyskinesia - systolic thinning and outward systolic wall motion). 3. For Group D: Had a clinically indicated pyridamole PSE (without contraindications for receiving pyridamole) either before or during screening with the following results: a)Adequate image quality with 4 or more segments evaluable in each view (apical 4-chamber, apical 3-chamber, and apical 2-chamber view) b) At rest, definitively normal perfusion and generally normal wall motion (defined as = 2 segments with wall motion abnormalities) and, with stress, definitively abnormal perfusion (delayed or absent replenishment of contrast after a high MI destruction pulse sequence) with or without abnormal wall motion. Note: Patients who have not had a dipyridamole PSE, but who are referred for clinically indicated stress echocardiography and for whom pyridamole PSE is clinically appropriate may undergo the qualifying dipyridamole PSE at screening. The results of that qualifying dipyridamole PSE must meet the above criteria before the patient may be enrolled in the protocol. 4. During the interval between the clinically indicated dobutamine (Groups A, B, B-1 and C) or dipyridamole (Group D) stress echocardiogram study and the regadenoson stress echocardiogram study the following conditions are required: a) Patients’ medical conditions must be stable (no change in symptoms) b) No change in cardioactive medications including but not limited to beta blockers, calcium channel blockers, long acting nitrates, ACE (angiotensin converting enzyme) inhibitors, ARBs (angiotensin II receptor blocking agents) and ranolazine c) No coronary intervention (PTCA or stenting). 5. By 8PM the night before the regadenoson dosing, patients who have not taken beta blockers before dobutamine/dipyridamole dosing in accordance with the site’s routine practice and are willing to do the same on the day of the regadenoson stress echocardiogram are eligible. Preferably but not mandatory, other cardioactive medications that may impact an ischemic reaction to stress (including but not limited to calcium channel blockers, long acting nitrates, ACE inhibitors, ARBs, ranolazine, etc.) should not have been taken before dobutamine/dipyridamole dosing, and the same medications should be withheld before regadenoson dosing. 6. For patients in Groups B, B-1 only: able to exercise at 25W for 5 minutes on an ergometer. 7. Adequate intravenous access in both arms. 8. Willing and able to comply with the requirements of the protocol and directions from clinic staff. 9. Provided written Informed Consent (approved by an appropriately constituted IRB/IEC) to participate in the study. 10. For female patients only: non-pregnant, non-lactating females must meet one of the following requirements: a) Post-menopausal (two years after the last menstrual period), or b) Su
Exclusion criteria
Exclusion criteria: 1. History of coronary artery bypass graft (CABG), or transmyocardial revascularization (TMR). 2. History of cardiac transplantation. 3. Acute or documented history of ST-segment elevation myocardial infarction (STEMI) or Non-ST-segment elevation myocardial infarction acute coronary syndrome (NSTEMI-ACS) within 3 months before enrollment. 4. History of greater than first degree AV block, sinoatrial block or sick sinus syndrome, atrial fibrillation, or serious uncontrolled ventricular arrhythmia (i.e., any life-threatening ventricular arrhythmia, such as ventricular arrhythmia with hemodynamic compromise). 5. Artificial pacemaker (functional) or implantable cardiac defibrillator [ICD] backup. 6. History of acute myocarditis or pericarditis, hypertrophic cardiomyopathy with resting gradient, severe aortic stenosis or other compromising structural heart disease that would, in the investigator’s judgment, compromise the safety of the patients during stress testing. 7. Concurrent or history of either symptomatic bradycardia or a resting heart rate of > 100 bpm. 8. Uncontrolled hypertension (> 200/120 mm Hg) within 30 days of study entry and patients who have shown an exaggerated pressor response to dobutamine. 9. Hypotension (cuff systolic blood pressure < 90 mm Hg supine) at the time of screening. 10. With respect to the qualifying echocardiongram: a) Groups A, B, B-1 and C: an exaggerated pressor response to dobutamine stress (hypotension or hypertension), clinically significant ventricular ectopy, or other major cardiovascular side effects that may jeopardize the safety of the patient b) Group D: hypersensitivity to dipyridamole, abnormalities of cardiac impulse formation or conduction, sever coronary artery disease, unstable angina, or other major side effects that may jeopardize the safety of the patient. 11. In patients for Groups B-1, C and D, any contraindications to receiving the echocardiogram contrast agent SonoVue including but not limited to: known hypersensitivity to sulphur, hexafluoride, or to any of the components of SonoVue; patients with right-to-left shunts, severe pulmonary hypertension, uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome; recent acute coronary syndrome or clinically unstable ischemic cardiac disease, including evolving or ongoing myocardial infarction, typical angina at rest with the last 7 days, significant worsening of cardiac symptoms within the last 7 days, recent coronary intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings); acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders; chest pain or ECG modification within the 2 days before dosing. 12. Known autonomic neuropathy with inadequate reaction to sympathetic stimulation (e.g. known inadequate heart rate increase under stress). 13. Current unstable or uncontrolled asthma or other reactive airways disease, or wheezing noted on physical exam. 14. Current treatment with theophylline/aminophylline preparations. 15. Known hypersensitivity to theophylline, aminophylline, adenosine or any of its constituents. 16. For both the qualifying echocardiogram as well as the regadenoson echocardiogram, unable to discontinue or refrain from: a) Dipyridamole for a period of 30 hours before each echocardiogram with the exception of the use of dipyrimadole as the stress agent for the qualifying echocardiogram for p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a 400 µg regadenoson bolus for pharmacological stress echocardiography by comparing the stress echocardiographic images obtained after dobutamine with those obtained after regadenoson alone, regadenoson with low-level exercise (25W), regadenoson with echocontrast agent, and by comparing PSE images obtained after dipyridamole with those obtained after regadenoson.;Secondary Objective: To evaulate the safety of regadenoson as a pharmacologic stress agent for echocardiography.;Primary end point(s): The study will continue until evaluable regadenoson and dobutamine/dipyridamole echocardiograms have been obtained for 10 patients in Groups A and B combined, and 10 patients each in Groups B-1, C and D. | — |
Countries
United Kingdom
Outcome results
None listed