Regadenoson vs Dipyridamole in Use as Pharmacological Stress Agent Before SPECT (REDUCE)

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Perfusion Imaging
• Intervention / Treatment: Other: collect examination time, functional and clinical tolerability

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dipyridamole; stress test impossible or contraindicated (first intention)	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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Christian SCHEIBER, Pr, Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2017
• Primary Completion (ACTUAL): October 9, 2017
• Study Completion (ACTUAL): October 9, 2017

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (ACTUAL): March 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL17_0056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No