Effects of Body Mass Index on the Hyperemic Response to Regadenoson

This study has been completed.

Study NCT00859833 Information provided by University of Utah

First Received on March 10, 2009. Last Updated on May 20, 2011 History of Changes

Results First Received: November 1, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Bio-equivalence Study; Intervention Model: Single Group Assignment; Masking: Single Blind (Subject); Primary Purpose: Diagnostic
Conditions:	Obesity Endothelial Dysfunction Decreased Vascular Flow
Interventions:	Drug: Adenosine Drug: Regadenoson

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from medical clinics and by advertising within the hospital.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Adenosine Followed by Regadenoson	Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson was given (0.4 mg) given as in i.v. bolus.

Participant Flow: Overall Study

	Adenosine Followed by Regadenoson
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Adenosine Followed by Regadenoson	Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.

Baseline Measures

	Adenosine Followed by Regadenoson
Number of Participants [units: participants]	30
Age [units: years] Mean ± Standard Deviation	49.5 ± 11.5
Age, Customized [units: participants]
Between 18 and 65 years	30
>=65 years	0
Gender [units: participants]
Female	13
Male	17
Region of Enrollment [units: participants]
United States	30

Outcome Measures

1. Primary:

Myocardial Perfusion Reserve Measured by Quantitative Perfusion MRI (Ratio of Myocardial Blood Flow During Stress Over Myocardial Blood Flow at Rest) [ Time Frame: 2 hours ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to technical problems, data from two of the 30 subjects was not usable.

Results Point of Contact:

Name/Title: Sheldon Litwin
Organization: Univesity of Utah
phone: 801-581-7715
e-mail: sheldon.litwin@hsc.utah.edu

No publications provided

Responsible Party:	Sheldon Litwin, M.D., Professor of Medicine, University of Utah
ClinicalTrials.gov Identifier:	NCT00859833 History of Changes
Other Study ID Numbers:	31431
Study First Received:	March 10, 2009
Results First Received:	November 1, 2010
Last Updated:	May 20, 2011
Health Authority:	United States: Food and Drug Administration