Impact of Nurse-led Programme With Carotid Ultrasound on Addressing Cardiovascular Risk in Patients With Arthritis

Chinese University of Hong Kong

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Arthritis, Rheumatoid Arthritis, Psoriatic

Interventions

AtorvastatinDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Medicine and Therapeutics

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

change in Framingham risk score

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.

Time frame: 12 months

Secondary Outcomes

Change in pulse wave velocity (PWV) in subjects

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

Time frame: 12 months

Change in augmentation index (AIX) in subjects

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

Time frame: 12 months

Change in individual modifiable risk factors levels

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.

Time frame: 12 months

The number of measures taken against comorbidities

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

Time frame: 12 months

Data from ClinicalTrials.gov

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