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single-arm for Coronary Artery Disease
Phase 4
Waitlist Available
Led By Dipan Shah, M.D.
Research Sponsored by Dipan Shah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days
Awards & highlights
Study Summary
This study is designed to evaluate the feasibility and diagnostic performance of a novel rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.
Eligible Conditions
- Coronary Artery Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR.
Secondary outcome measures
Evaluate time for performance of rapid regadenoson stress CMR protocol.
Side effects data
From 2014 Phase 4 trial • 20 Patients • NCT0087126045%
Dyspnea or difficulty with breath
35%
Palpitations
35%
Chest pressure or heaviness
25%
Flushing
10%
Dysgeusia immediately following aminophylline administration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Patients
Trial Design
1Treatment groups
Experimental Treatment
Group I: single-armExperimental Treatment1 Intervention
Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, regadenoson.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regadenoson
FDA approved
Find a Location
Who is running the clinical trial?
Dipan ShahLead Sponsor
3 Previous Clinical Trials
100,180 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
120 Patients Enrolled for Coronary Artery Disease
Astellas Pharma Global Development, Inc.Industry Sponsor
192 Previous Clinical Trials
121,036 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
1,259 Patients Enrolled for Coronary Artery Disease
Dipan Shah, M.D.Principal InvestigatorThe Methodist Hospital Research Institute
Frequently Asked Questions
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