Regadenoson vs Dipyridamole in Use as Pharmacological Stress Agent Before SPECT

NCT ID: NCT03084562

Last Updated: 2018-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-03

Study Completion Date

2017-10-09

Brief Summary

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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

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Conditions

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Myocardial Perfusion Imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dipyridamole

stress test impossible or contraindicated (first intention)

collect examination time, functional and clinical tolerability

Intervention Type 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

Regadenoson

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

collect examination time, functional and clinical tolerability

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian SCHEIBER, Pr

Role: PRINCIPAL_INVESTIGATOR

Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service

Locations

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Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service

Bron, , France

Site Status

Countries

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France

Other Identifiers

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69HCL17_0056

Identifier Type: -

Identifier Source: org_study_id

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