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

Arthritis, Rheumatoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03625089
• Other study ID #: IA_2017
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Department of Medicine and Therapeutics	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportions of patients achieving remission	Proportions of patients achieving remission between two group to evaluate outcome upon treat-to-target protocol	12 months
Secondary	Changes in intima-media thickness (IMT)	Changes in IMT (mm) in subjects between 2 groups after intervention by using high-resolution ultrasound	12 months
Secondary	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