<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2282620150719N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-19</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of combined of supplement with carnitine and coenzyme Q10, versus therapeutic lifestyle changes (TLC Diet) diet on  myocardial infarction  patients.</public_title>
      <acronym>Therapeutic Lifestyle Changes Diet (TLC)</acronym>
      <scientific_title>Evaluation of effects of combined of supplement with carnitine and coenzyme Q10, versus therapeutic lifestyle changes (TLC Diet) diet on cardiovascular risk factors, function and quality of life after angioplasty in patients with experience of myocardial infarction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-05-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19603</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: control group: without any intervention, patient receive routine care. Intervention 2: Diet and supplement group: patient receive therapeutic life style change diet and two supplement , l-carnitin with dose 1200 mg , co- Q10 with dose 150 mg. Intervention 3: Diet  group: patient receive therapeutic life style change diet  suitable with weight and individual properties. Intervention 4: supplement group: patient receive  two supplement , l-carnitin with dose 1200 mg , co- Q10 with dose 150 mg.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Hassan Eftekhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Blov modarres, Blov razi,School of  Nutrition and Food Sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71645-111</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>h_eftekhar@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hassan Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Blov.modaress,Blov. razi,  School of Nutrition and Food Sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71645111</zip>
        <telephone>+98 71 3725 7288</telephone>
        <email>h_eftekhar@yahoo.com</email>
        <affiliation>School of Nutrition and Food Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria:&#13;
first experience of myocardial infarction;&#13;
age between 40 -65;&#13;
candidate for angioplasty revascularization;&#13;
LDL &gt;130؛&#13;
without anti lowering lipid six month ago;&#13;
ejection fraction between 30-60;&#13;
receive atorvastatin 80 mg daily;&#13;
&#13;
exclusion criteria:&#13;
allergy with atorvastatin; &#13;
history of cardiac event after  angioplasty;&#13;
 patient with arrhythmia or congestive heart failure;&#13;
history of consumption of antioxidant such as vitamin C, E and omega 3;&#13;
history of consumption warfarin;&#13;
history of  documented psychological disease ;&#13;
leave the patient before 60 days after intervention in RCT;</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>control group: without any intervention, patient receive routine care</i_keyword>
      <i_keyword>Diet and supplement group: patient receive therapeutic life style change diet and two supplement , l-carnitin with dose 1200 mg , co- Q10 with dose 150 mg</i_keyword>
      <i_keyword>Diet  group: patient receive therapeutic life style change diet  suitable with weight and individual properties</i_keyword>
      <i_keyword>supplement group: patient receive  two supplement , l-carnitin with dose 1200 mg , co- Q10 with dose 150 mg</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>LDL. Timepoint: 24 hours after myocardial infarction than 3 month after intervention. Method of measurement: enzymatic method calculate.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: 10 days  after myocardiad in farction. Method of measurement: MacNew questionaire.</sec_outcome>
      <sec_outcome>Ejection fraction. Timepoint: 24 houre after myocardiad in farction. Method of measurement: echocardiography   by specilalist.</sec_outcome>
      <sec_outcome>Triglyceride (TG). Timepoint: 24 houre after myocardiad in farction and 3 mouth after intervention. Method of measurement: Photometric method.</sec_outcome>
      <sec_outcome>High-density lipoprotein (HDL). Timepoint: 24 houre after myocardiad in farction and 3 mouth after intervention. Method of measurement: Photometric method.</sec_outcome>
      <sec_outcome>Physical Activity. Timepoint: 7  days before myocardial infarction  then 3 month after intervention. Method of measurement: Intinternational Physical Activity Questionnaire - Short Form (IPAQ-SF).</sec_outcome>
      <sec_outcome>H- CRP. Timepoint: 24 houre after myocardiad in farction and 3 mouth after intervention. Method of measurement: ELISA   by micropipette reader.</sec_outcome>
      <sec_outcome>IL-6. Timepoint: 24 houre after myocardiad in farction and 3 mouth after intervention. Method of measurement: ELISA.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-19</approval_date>
        <contact_name>Shiraz UniversityMedical Sciences</contact_name>
        <contact_address>Zand Blov,Shiraz University Medical Sciences Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
