N/A Completed N=48 Diagnostic

Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)

Coronary Artery Disease

Source: ClinicalTrials.gov NCT01482169 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcomePrimary: Comparing Measurement of Fractional Flow Reserve (FFR) — .83; .84 FFR

Summary

The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparing Measurement of Fractional Flow Reserve (FFR)	.83; .84	—
SECONDARY Duration to Baseline Hyperemia After Aminophylline Injection	112	—

Eligibility Criteria

Inclusion Criteria

Patients undergoing elective left heart catheterization
Age ≥ 18 years (female not of child bearing potential)
Able to provide written informed consent

Exclusion Criteria

Contraindications to administration of either Adenoscan® or Regadenoson
High degree AV block, sick sinus syndrome without a functioning pacemaker
Symptomatic bradycardia
Recent STEMI ( 1000 IU
Dipyridamole use within 24 hours
Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or aminophylline
Known severe bronchoconstrictive lung disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01482169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.