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

NCT ID: NCT03625089

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-09-30

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.

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1 - FRS arm

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%

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

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.

Group 2 USG arm

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

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

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.

Interventions

Atorvastatin

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.

Intervention Type: DRUG

Other Intervention Names

Lipitor

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Lai-Shan Tam

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lai Shan Tam, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Department of Medicine and Therapeutics

Hong Kong, , Hong Kong

Countries

Hong Kong

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IA_2017

Identifier Type: -

Identifier Source: org_study_id