Endothelial Hyperpolarization in Humans

This study has been terminated.
(Limited clinical staff)
Sponsor:
Information provided by (Responsible Party):
Arshed A. Quyyumi, Emory University
ClinicalTrials.gov Identifier:
NCT00166166
First received: September 13, 2005
Last updated: May 12, 2015
Last verified: May 2015
Results First Received: May 8, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Hyperlipidemia
Interventions: Drug: Tetraethylammonium (TEA)
Drug: L-NG-monomethyl Arginine (L-NMMA)
Drug: Bradykinin
Drug: Sodium nitroprusside
Drug: Acetylcholine
Drug: Saline
Drug: Fluconazole

  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
No text entered.

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
Healthy Controls Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
Risk Factors Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine

Participant Flow:   Overall Study
    Healthy Controls     Risk Factors  
STARTED     103     71  
COMPLETED     103     71  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics represent subjects that completed the study.

Reporting Groups
  Description
Healthy Controls Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
Risk Factors Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
Total Total of all reporting groups

Baseline Measures
    Healthy Controls     Risk Factors     Total  
Number of Participants  
[units: participants]
  103     71     174  
Age  
[units: years]
Mean (Standard Deviation)
  34  (11)     46  (12)     40  (12)  
Gender  
[units: participants]
     
Female     49     32     81  
Male     54     39     93  



  Outcome Measures
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1.  Primary:   Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration   [ Time Frame: Baseline, 5 minutes ]

2.  Primary:   Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA)   [ Time Frame: Baseline, 5 minutes ]

3.  Secondary:   Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA)   [ Time Frame: 5 minutes, 10 minutes ]

4.  Secondary:   Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration   [ Time Frame: Baseline, 5 minutes ]

5.  Secondary:   Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration   [ Time Frame: 5 minutes, 10 minutes ]

6.  Secondary:   Percent Change in Forearm Blood Flow (FBF) After Fluconazole and Tetraethylammonium (TEA) Administration   [ Time Frame: 5 minutes, 10 minutes ]

7.  Secondary:   Forearm Blood Flow (FBF) After Sodium Nitroprusside Administration   [ Time Frame: 5 minutes ]

8.  Secondary:   Change in Tissue Plasminogen Activator (t-PA) Release   [ Time Frame: Baseline, 30 minutes ]

9.  Secondary:   Change in Tissue Plasminogen Activator (t-PA) Release After Tetraethylammonium (TEA) and Bradykinin Administration   [ Time Frame: 30 minutes, 60 minutes ]

10.  Secondary:   Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole and Bradykinin Administration   [ Time Frame: 30 minutes, 60 minutes ]

11.  Secondary:   Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole, Tetraethylammonium (TEA), and Bradykinin Administration   [ Time Frame: 60 minutes, 90 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Findings are limited to the forearm microcirculations, thus other vascular beds including conductance arteries warrant further investigation. Nevertheless, it is known that the contribution of EDHF is less in conductance vessels than in microvessels.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Arshed Quyyumi
Organization: Emory University
phone: 404-727-3655
e-mail: aquyyum@emory.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Arshed A. Quyyumi, Emory University
ClinicalTrials.gov Identifier: NCT00166166     History of Changes
Other Study ID Numbers: IRB00021886, 1 RO1 HL079115-01, 0605-2002
Study First Received: September 13, 2005
Results First Received: May 8, 2015
Last Updated: May 12, 2015
Health Authority: United States: Food and Drug Administration