Regadenoson vs Dipyridamole in Use as Pharmacological Stress Agent Before SPECT

Completed

• Conditions: Myocardial Perfusion Imaging
• Interventions: Other: collect examination time, functional and clinical tolerability

• Registration Number: NCT03084562
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Study Start: 2017-05-03
• Primary Completion: 2017-10-09
• Study Completion: 2017-10-09
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dipyridamole	collect examination time, functional and clinical tolerability	stress test impossible or contraindicated (first intention)
Regadenoson	collect examination time, functional and clinical tolerability	stress test and dipyridamole impossible or contraindicated. In particular, patients with severe COPD or asthmatic patient. (second intention)

Primary Outcome Measures

Name	Time	Method
Duration of the test	24 hours (Visit 1: During the examen)	Evaluate the time savings from the use of regadenoson versus dipyridamole by comparing the duration of the test.

Trial Locations

Locations (1)

Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service; 🇫🇷 Bron, France