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NCT01161121 · ClinicalTrials.gov registry record · Phase 1

Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia

A Phase 1 study of Coronary Artery Disease, sponsored by St. Louis University.

Completed
Registry status
Phase 1
Development phase
46
Enrollment target
2
Study locations

NCT01161121 is a Phase 1 study of Coronary Artery Disease that has completed, run by St. Louis University. The registered enrollment target is 46 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01161121, a Phase 1 study of Coronary Artery Disease, has completed, sponsored by St. Louis University.

COMPLETED
Registry status
Phase 1
Development phase
46 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to determine if regadenoson is as safe and effective as adenosine when used in the cardiac catheterization lab during measurement of coronary flow reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional Flow Reserve (FFR) in the catheterization lab can be performed with equivalent accuracy when hyperemia is induced with IV Regadenoson compared with IV Adenosine without compromising patient safety.

Conditions Studied

Interventions

  • DRUG adenosine
  • DRUG regadenoson

Study Locations (2)

Florida

  • University of Florida - Jacksonville

Missouri

  • St. Louis University - St Louis

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2010-07
Est. Completion 2013-04
Phase Phase 1

Sponsor

St. Louis University

107 total trials

What the Registry Record Tells You About NCT01161121

The ClinicalTrials.gov registry entry for NCT01161121 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (96% lower). The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which adenosine is the first listed.

NCT01161121 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Missouri.

Frequently Asked Questions

What is clinical trial NCT01161121 about?

NCT01161121 is a clinical study titled "Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia". The purpose of this study is to determine if regadenoson is as safe and effective as adenosine when used in the cardiac catheterization lab during measurement of coronary flow reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional Flow Reserve (FFR) in the catheter...

What is the current status of trial NCT01161121?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2010-07. Estimated completion is 2013-04.

What conditions does trial NCT01161121 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

What interventions are being tested in trial NCT01161121?

The interventions under investigation include: adenosine (DRUG), regadenoson (DRUG).

Who is sponsoring clinical trial NCT01161121?

This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01161121 being conducted?

This trial has 2 study locations across Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.