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

NCT03625089 | Withdrawn

• 1 other identifier: IA_2017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Keywords

Carotid Atherosclerosis; Arterial Stiffness; Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in pulse wave velocity (PWV) in subjects

  12 months

• Change in augmentation index (AIX) in subjects

  12 months

• Change in individual modifiable risk factors levels

  12 months

• The number of measures taken against comorbidities

  12 months

• Proportions of patients achieving remission

  12 months

Study Arms (2)

Group 1 - FRS arm

ACTIVE COMPARATOR

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 2 USG arm

EXPERIMENTAL

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

Drug: Atorvastatin

Interventions

Atorvastatin 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.

Also known as: Lipitor

Group 1 - FRS arm; Group 2 USG arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine and Therapeutics

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Carotid Artery Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Lai Shan Tam, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 10, 2018
• Study Start: September 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)