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CompletedNCT03084562REDUCEUpdated Apr 13, 2018

Regadenoson vs Dipyridamole in Use as Pharmacological Stress Agent Before SPECT

An observational study in Myocardial Perfusion Imaging, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-13.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

Myocardial perfusion scintigraphy is to evaluate coronary perfusion as well as heart muscle function. This examination takes place in two stages, one imaging at rest and one after a cardiac stress caused. This stress can be triggered as a first-line stress test. A pharmacological stress is proposed when stress test is not possible or contraindicated, Several drugs have a marketing authorization in this indication (adenosine, dipyridamole, regadenoson, dobutamine).

Among them, the regadenoson is the most recent molecule. Marketed in France since 2013, it would allow a reduction of undesirable effects compared to other agents, especially adenosine. It is simple and quick to use thanks to a single dose administration. However, its cost is nearly 30 times higher than dipyridamole. In the investigational center, dipyridamole is currently the first-line pharmacological stress agent, whereas regadenoson is reserved for a limited number of doses, the indication of which must be justified (asthmatic patient or with severe COPD). Few studies in the literature specifically compare these two pharmacological agents (examination time, cost, tolerance) and the opinion on the use of regadenoson in the service is limited.

02

Conditions studied

  • Myocardial Perfusion Imaging
03

In context

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients reffered for an indication of myocardial perfusion scintigraphy in the nuclear medicine unit

Eligibility criteria

Inclusion Criteria:

  • Adult ≥ 18 years
  • Myocardial scintigraphy by pharmacological stress agent
  • Used molecules = Dipyridamole or Regadenoson

Exclusion Criteria:

  • Physical stress test by single or mixed effort (associating pharmacological stress)
  • Pharmacological agent used = Adenosine
  • Inclusion in the ERCAD protocol
  • Double isotope protocol
  • Patient refusal due to study information
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • Dipyridamole

    stress test impossible or contraindicated (first intention)

    Other: collect examination time, functional and clinical tolerability

  • Regadenoson

    stress test and dipyridamole impossible or contraindicated. In particular, patients with severe COPD or asthmatic patient. (second intention)

    Other: collect examination time, functional and clinical tolerability

Interventions

  • Othercollect examination time, functional and clinical tolerability

    Examination time : time from patient setup and launch of the pre-test to the end of the patient monitoring Functional tolerability : functional assessed by the patient Clinical tolerability : clinical score by the cardiologist

06

What researchers measure

Primary outcomes

  1. Duration of the test

    Evaluate the time savings from the use of regadenoson versus dipyridamole by comparing the duration of the test.

    Time frame: 24 hours (Visit 1: During the examen)

07

Study locations

1 site
  • Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service
    Bron, 69677, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03084562
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Mar 21, 2017
Start date
May 3, 2017
Primary completion
Oct 9, 2017
Completion
Oct 9, 2017
Last update
Apr 13, 2018

Study contacts

Christian SCHEIBER, Pr
principal investigator · Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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