Clinical trial NCT01917123: The Effect of L-Citrulline Malate on Ankle Brachial Index Among Patients With Coronary Heart Disease
Official title: Phase 0 Study of The Effect of L-Citrulline Malate on Ankle Brachial Index Among Patients With Coronary Heart Disease According to Their Smoking History
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Coronary Heart Disease
Keywords: L-Citrulline malate,Coronary Heart Disease, Brachial Index
Lead sponsor: Masih Daneshvari Hospital
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2013-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized clinical trial before and after study we will assess the effect of L-citrulline malate on brachial index in patients with coronary heart disease based on their smoking history. Twenty patients with coronary heart disease with no history of diabetes or other chronic diseases and with no history of myocardial infarction in the last 6 months will participate in our trial.A written well-versed permission was attained from all patients. We will measure the brachial index tow times once before giving L-Citrulline malate and the other time after 2 weeks giving it.Patients receiving L-Citrulline malate as a 1 gram dry powder agent twice a day, that should in use with 250 mg dilute water .The patients will followed after 2 weeks by measuring brachial index which is our primary outcome measurement in this trial.We assumed that the brachial index in both smoker and non-smoker group of patients with coronary heart disease would change to normal or close to normal after giving 1 gram L-citrulline malate twice a day for 2 weeks.


Eligibility criteria: Inclusion Criteria:

1- patients with coronary heart disease without history of diabetes or any chronic disease 2- no myocardial infarction in last 6 months 3-ejection fraction more than 50% 4- please to recruit in the trial 5-no uncontrolled blood pressure 6- with stable condition when come to the clinic

Exclusion Criteria:

1- those who refuse to being in the trial 2- those which their total condition become worse 3- CCU admission as a result of being unstable 4- patients with chronic heart failure(CHF)

Primary outcomes:
measure: Brachial Index
timeFrame: 2 weeks
Secondary outcomes:
measure: Brachial Index
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital
Study officials:
affiliation: Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Babak Sharif-Kashani, Cardiologist
role: STUDY_DIRECTOR
affiliation: Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Shabnam Eslam-Panah, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Paritash Tahmaseb-pour, M.D
role: PRINCIPAL_INVESTIGATOR
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