Regadenoson vs Dipyridamole in Use as Pharmacological Stress Agent Before SPECT

NCT03084562 | Completed

• 1 other identifier: 69HCL17_0056
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Perfusion Imaging

Outcome Measures

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.

  24 hours (Visit 1: During the examen)

Study Arms (2)

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

collect examination time, functional and clinical tolerability OTHER

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

Dipyridamole; Regadenoson

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service

Bron, 69677, France

Location

MeSH Terms

Interventions

Functional Status

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Christian SCHEIBER, Pr

  Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 21, 2017
• Study Start: May 3, 2017
• Primary Completion: October 9, 2017
• Study Completion: October 9, 2017
• Last Updated: April 13, 2018

Record last verified: 2017-03

Locations

FR (1)