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

The Impact of Nurse-led Programme With and Without Carotid Ultrasound on Addressing Cardiovascular Risk in Patients With Arthritis: a Prospective, Multicentre, Randomised, Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Arthritis, Rheumatoid; Arthritis, Psoriatic
• Intervention / Treatment: Drug: Atorvastatin

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Medicine and Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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%	Drug: 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.; Other Names: Lipitor
Experimental: 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..	Drug: 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.; Other Names: Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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	12 months
Proportions of patients achieving remission	Proportions of patients achieving remission between two group to evaluate outcome upon treat-to-target protocol	12 months
Changes in intima-media thickness (IMT)	Changes in IMT (mm) in subjects between 2 groups after intervention by using high-resolution ultrasound	12 months
Proportion of plaque progression	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	12 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Arterial Stiffness; Cardiovascular Risk; Carotid Atherosclerosis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: IA_2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No