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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
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
All Individual Drugs Already Approved

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 weeks
Treatment ~ Varies
Follow Up ~up to 7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR.
Secondary study objectives
Evaluate time for performance of rapid regadenoson stress CMR protocol.

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT00871260
45%
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
199 Previous Clinical Trials
122,304 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
~4 spots leftby Nov 2025
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