To evaluate the efficacy of ACC/AHA 2013 guidelines in high risk and low risk individuals
Design
Randomized controlled trial with parallel design
Group 1 high risk patients according to Reynold,s Risk score, receiving lifestyle modification based on ACC/AHA guideline and medication
Group 2 low risk patients according to Reynold,s Risk score, receiving lifestyle modification based on ACC/AHA guideline
Two groups of study have been classified according to Reynold,s Risk scores and there were no random assignment.
The clinical trial phase is Phase 2-3
Settings and conduct
A clinical trial with two arms and parallel design allocated 322 participants into intervention arms according to ACC/AHA 2013 guideline. Baseline Reynolds risk score (RRS) allocated study population into low risk RRS≤ 7.5 and high risk group RRS>7.5. Interventions were consisted of life style intervention for low risk arm. High risk group received life style interventions associated with statin (Atorvastatin 20 mg) therapy for individuals with elevated high sensitive C-reactive protein (Hs-CRP). After completion of follow up outcomes were evaluated and compared by repeated measurement analysis.
Participants/Inclusion and exclusion criteria
inclusion criteria:
individuals with age above 20 years
without history of confirmed CAD
exclusion criteria: non compliance
Intervention groups
We allocated life style intervention for low riskReynold,s risk score ( RRS) <7.5 arm. High risk RRS>7.5 group received life style interventions associated with statin (Atorvastatin 20 mg) therapy for individuals with elevated high sensitive C-reactive protein (Hs-CRP).
Main outcome variables
change in risk factors level from baseline
change in Reynolds risk score from baseline
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181003041218N1
Registration date:2018-12-18, 1397/09/27
Registration timing:retrospective
Last update:2018-12-18, 1397/09/27
Update count:0
Registration date
2018-12-18, 1397/09/27
Registrant information
Name
zinat hatmi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6405 3219
Email address
hatmizn@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2015-04-04, 1394/01/15
Actual recruitment start date
2014-04-04, 1393/01/15
Actual recruitment end date
2015-04-09, 1394/01/20
Trial completion date
2015-09-21, 1394/06/30
Scientific title
A primary prevention trial of coronary artery disease risk factors modification by using 2013 ACC/AHA guidelines
Public title
efficacy of 2013 ACC/AHA guideline in primary prevention of coronary artery disease (CAD)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
men and women aged over 20 years
without previously diagnosed CAD
Exclusion criteria:
non compliance
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
322
Actual sample size reached:
322
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome evaluation, data analyzing and monitoring of the project were all blinded.A concealment code has been asigned to each patients, therefore, medical providers who evaluate the risk factor changes according to physical examination and laboratory tests were blinded about patients group of high risk versus low risk one. Moreover,statisticain who analyzed data and project monitoring person were all blinded about study groups.
Placebo
Not used
Assignment
Parallel
Other design features
None
Secondary Ids
1
Registry name
none
Secondary trial Id
none
Registration date
2018-10-20, 1397/07/28
Ethics committees
1
Ethics committee
Name of ethics committee
Medical faculty of Tehran University of medical sciences (TUMS)
Street address
Second floor, Building Number 1 , Purcina Ave, Keshavarz Bulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2014-04-09, 1393/01/20
Ethics committee reference number
1393-25239
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
Primary outcomes
1
Description
Mean of systolic blood pressure in mm Hg from baseline
Timepoint
10 months from baseline
Method of measurement
In clinic with standardized sphygmomanometer
2
Description
Mean change in diastolic blood pressure in mm Hg from baseline
Timepoint
10 months from baseline
Method of measurement
In clinic with standardized sphygmomanometer
3
Description
Mean change in total cholesterol in milligram / deciliter from baseline
Timepoint
10 months from baseline
Method of measurement
Laboratory enzymatic method
4
Description
Mean change in fasting blood sugar in milligram / deciliter from baseline
Timepoint
10 months from baseline
Method of measurement
Laboratory enzymatic method
5
Description
Mean change in Reynolds risk score from baseline
Timepoint
10 months from baseline
Method of measurement
statistical calculation method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : lifestyle modification according to 2013 ACC/AHA guideline in addition to Atorvastatin 20 mg for individual with RRS>7.5 and Hs-CRP>3
Category
Prevention
2
Description
Intervention group2: lifestyle modification according to 2013 ACC/AHA guideline in order to change risk factors level from base