Arthritis, Psoriatic, Arthritis, Rheumatoid
Conditions
Keywords
Carotid Atherosclerosis, Arterial Stiffness, Cardiovascular Risk
Brief summary
Elevated CVD risk is a significant public health problem that contributes greatly to the increased morbidity and shortened lifespan of individuals with RA and PsA. Over the past decades, there has been great progress into the understanding of the severity of CVD risk in these patients but these risk factors are not well managed. The development of the high-risk strategy is therefore necessary, with more intensive therapy reserved for patients identified as high-risk, e.g. because they have high-risk FRS. However, these risk scores under-estimated CV risk in patients with RA and PsA. An intermediate approach is to use quantification of preclinical vascular disease to further identify high-risk patients. Results from this study will provide clinical implications in terms of detecting and managing cardiovascular morbidity in patients with RA and PsA.
Detailed description
Objectives This study investigates the impact of a nurse-led programme on cardiovascular (CV) risk screening with and without carotid ultrasound for carotid plaque on CV risk factor control in asymptomatic rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients. Hypothesis The investigators hypothesize that CV risk stratification and management in RA and PsA may be improved by incorporation of carotid ultrasound to assess for carotid plaque.
Interventions
DRUGAtorvastatin
Group 1 patients will be prescribed statin when FRS \> 10%; while group patients will be prescribed statin upon presence of carotid plaque as reported from carotid ultrasound. The decision will solely be made base on the randomized group by either FRS\>10% or presence of carotid plaque. Atorvastatin 20 mg is recommended as the preferred initial high intensity statin to use because it is clinically and cost effective for the primary prevention of CVD according to the national institute for Health and Care Excellence (NICE) guideline from the United Kingdom.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with RA fulfilled the 2010 ACR/EULAR classification criteria or PsA fulfilled the Classification of Psoriatic Arthritis (CASPAR) criteria * aged between 18 and 75 will be recruited.
Exclusion criteria
* had a history of overt CVD (ie, symptomatic coronary artery disease \[CAD\] or ischemic stroke or transient ischemic attack or peripheral vascular disease) * had significant co-morbidities including severe renal impairment or severe deranged liver function * female of childbearing potential who are unwilling to use adequate contraception, pregnant or breastfeeding women * patients who are already taking lipid lowering therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Framingham risk score | 12 months | The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more. Change in Framingham risk score between subject in two group will be evaluated. A positive change in score indicates increased CV risk, vice versa. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in augmentation index (AIX) in subjects | 12 months | Change in arterial stiffness in terms of AIX (%)in subjects between subject in two group, as a parameter to capture change in CV risk upon intervention |
| Change in individual modifiable risk factors levels | 12 months | Target for individual modifiable risk factor will be set (For subject with diabetes, target is Hba1c\<7.0%; for dyslipidaemia subject, target is LDL\<2.6 mmol/l; for obese subject, target is drop in BMI for 1 unit; for smoker, target is smoking cessation; for all subject, physical activity level target is at least once per week with not less than 30 min activity) Change total number of modifiable risk factor achieved target will be computed. |
| The number of measures taken against comorbidities | 12 months | The number of measures taken against commodities (including home blood pressure monitoring, attending dietitian education class, compliance to drug etc) after implementation of nurse led clinic |
| Change in pulse wave velocity (PWV) in subjects | 12 months | Change in arterial stiffness in terms of PWV (cm/s) in subjects between subject in two group, as a parameter to capture change in CV risk upon intervention |
| Changes in intima-media thickness (IMT) | 12 months | Changes in IMT (mm) in subjects between 2 groups after intervention by using high-resolution ultrasound |
| Proportion of plaque progression | 12 months | Proportion of plaque progression in subjects between 2 groups after intervention by using high-resolution ultrasound. Plaque progression defined as increase in area harboring plaque or increased number of plaque |
| Proportions of patients achieving remission | 12 months | Proportions of patients achieving remission between two group to evaluate outcome upon treat-to-target protocol |
Countries
Hong Kong
Outcome results
None listed