Regadenoson vs Dipyridamole in Use as Pharmacological Stress Agent Before SPECT

Myocardial Perfusion Imaging Clinical Trial

— REDUCE  

Official title:

Descriptive Study Comparing Regadenoson Versus Dipyridamole in Use as Pharmacological Stress Agent Before a Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (SPECT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084562
• Other study ID #: 69HCL17_0056
• Status: Completed
• First received: March 8, 2017
• Last updated: April 12, 2018
• Start date: May 3, 2017
• Est. completion date: October 9, 2017

Study information

• Verified date: March 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 9, 2017
• Est. primary completion date: October 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Perfusion Imaging

Intervention

Other:
• collect 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

Locations

Country	Name	City	State
France	Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the test	Evaluate the time savings from the use of regadenoson versus dipyridamole by comparing the duration of the test.	24 hours (Visit 1: During the examen)