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

The Chinese University of Hong Kong

Status: Withdrawn

Conditions: Arthritis, Psoriatic; Arthritis, Rheumatoid

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03625089

IA_2017

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group 1 - FRS arm

Active Comparator group

Description:

Both group will participate in the nurse-led programme on CV risk screening and carotid ultrasound for carotid plaque assessment. Subjects in group 1 will initiate Atorvastatin treatment (20mg daily per oral) if their Framingham Risk Score \>10%

Treatment:

Drug: Atorvastatin

Group 2 USG arm

Experimental group

Description:

Subjects in group 2 will initiate Atorvastatin treatment (20mg daily per oral) if they had carotid plaque upon carotid ultrasound findings..

Treatment:

Drug: Atorvastatin