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Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients

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ClinicalTrials.gov Identifier: NCT02638727
Recruitment Status : Unknown
Verified December 2015 by Mohammad Ali Akbarzadeh, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Mohammad Ali Akbarzadeh, Shahid Beheshti University of Medical Sciences

Brief Summary:
The purpose of this study is to determine the efficacy of oral L-Citrulline on endothelial function and vasodilation in patients with coronary artery disease(CAD) by evaluating the brachial artery diameter in the antecubital area by ultrasonography.

Condition or disease Intervention/treatment Phase
Vascular Disease Drug: L-Citrulline Drug: placebo Not Applicable

Detailed Description:

Before prescribing the drug or placebo, the patients were evaluated via the ultrasound machine equipped. The brachial artery diameter in the antecubital area was measured by the ultrasound and was recorded. Then blood pressure cuff was attached on the arm and dilated 50mmhg above the systolic pressure and for 5 minutes remained the same level to induce ischemia at distal tissues until the occurrence of compensatory vasodilatation. Then the brachial artery diameter (as an estimation of FMD) was measured and recorded. After 4 minutes of administration of 2 puffs of nitroglycerin spray, the brachial artery diameter (as an estimation of NMD) was measured.

After 15 days treatment with the L-Citrulline or the placebo, the patients underwent the ultrasonography again and the above assessments were done.

Improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription) is determined as "improvement of flow mediated dilation to nitroglycerin dependent vasodilation" evaluate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients:A Randomized Crossover Clinical Trial
Study Start Date : December 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Drug Arm
This group treat with L-Citrulline (3 grams per day)
Drug: L-Citrulline
This group treat with L-Citrulline (3 grams per day)

Placebo Comparator: Placebo Arm
this group treat with placebi every day
Drug: placebo
This group treat with placebo dayley




Primary Outcome Measures :
  1. improvement of flow mediated dilation to nitroglycerin dependent vasodilation [ Time Frame: 15 days ]
    improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio less than 1

Exclusion Criteria:

  • no documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio equal /more than 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638727


Contacts
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Contact: Isa Khaheshi, MD 00989125441637 isa_khaheshi@yahoo.com

Locations
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Iran, Islamic Republic of
Shahid Modaress Hospital , Tehran, Iran Recruiting
Tehran, Iran, Islamic Republic of
Contact: Isa Khaheshi, MD    00989125441637    isa_khaheshi@yahoo.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Study Director: Morteza Safi, MD Cardiovascular Research Center
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Responsible Party: Mohammad Ali Akbarzadeh, sistant proffesor of shahid beheshti university of medical sciences, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02638727    
Other Study ID Numbers: CVRC101
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Keywords provided by Mohammad Ali Akbarzadeh, Shahid Beheshti University of Medical Sciences:
vascular disease
endothelial function
L-Citrulline
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases