Safety and Accuracy Study of Regadenoson Atropine Combination for Stress Echocardiography in Identification of Coronary Artery Disease (REGAT)
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 |
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
Inclusion Criteria:
- Age > 18 years old
- Able to provide consent
- Scheduled for cardiac catheterization either with or without a prior functional stress imaging study
Exclusion Criteria:
- Any history of acute myocardial infarction, prior PCI in last 3 months, bypass surgery,
- History of greater than first degree AV block, sick sinus syndrome in patients
- Patients with a pacemaker/LBBB
- History on uncontrolled arrhythmias
- Patients with significant pulmonary disease, known or suspected bronchoconstrictive or bronchospastic lung disease or other hypersensitivity to adenosine
- History of cardiac transplantation, hypertrophic cardiomyopathy, acute myocarditis or pericarditis, severe valvular heart disease
- Hemodynamically unstable patients
- 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
- History of glaucoma or obstructive uropathy
- Allergy or hypersensitivity to atropine
- Participation in another investigational drug study within 1 month or participation in any previous regadenoson trial
- Pregnancy, breast feeding, or not using an acceptable method of birth control (if premenopausal)
- . History of end-stage renal disease on hemodialysis or peritoneal dialysis
Contacts and Locations| Contact: Karthikeyan Ananthasubramaniam, MD FACC | 313-916-2721 | kananth1@hfhs.org |
| Contact: Dee Dee Wang, MD | 313-916-2721 | DWANG2@hfhs.org |
| 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 | |
| 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 Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Atropine Regadenoson Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents |
Cardiovascular Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Mydriatics Parasympatholytics Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adenosine A2 Receptor Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013