GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL

Dyslipidemia Clinical Trial

— GOAL QuERI  

Official title:

Guidelines Oriented Approach to Lipid Lowering Quality Enhancement Research Initiative (GOAL QuERI) International

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03861533
• Other study ID #: CHRC2019-GOAL INT
• Status: Active, not recruiting
• Start date: April 1, 2019
• Est. completion date: April 1, 2023

Study information

• Verified date: March 2022
• Source: Canadian Heart Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This Quality Enhancement Research Initiative (QuERI) is a knowledge translation medical practice activity based on decision making support through feedback to physicians on their management of dyslipidemia in order to achieve guidelines recommended LDL-C levels in high risk patients. Physician interaction has three distinct components: 1. Capture of data as reported by participating physician; 2. Highlight (by providing feedback) where management may be optimized based on guidelines or recommendations; 3. Identify challenges faced by physicians resulting in the care gap..

Description:

The GOAL QuERI International will engage approximately 115 health care practitioners (HCP) who will enroll up to 2500 patients with management observations based on four visits by the patients in an outpatient setting. The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture form (DCF). The DCF will be created and managed by the CHRC.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults = 18 years old

2. High risk for cardiovascular morbidity and mortality such as prior history of clinical cardiovascular disease and/or history of familial hypercholesterolemia

3. LDL-C within the past 6 months above recommended level despite maximal tolerated statin therapy ± ezetimibe for the past 3 months.

Exclusion Criteria:

1. Current treatment with PCSK9 inhibitor

2. Current participation in investigational study

3. Prior participation in the GOAL program

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Other:
• survey
Cross-Reference

Locations

Country	Name	City	State
Kuwait	Sabah Hosptial	Kuwait
Mexico	Centro de Estudios Clínicos de Querétaro (CECLIQ)	Querétaro	Qro
Saudi Arabia	King Fahd Military Medical Complex	Dhahran
United Arab Emirates	Cleveland Clinic	Abu Dhabi

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Anatoly Langer	Amgen

Countries where clinical trial is conducted

Kuwait,  Mexico,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving country specific guideline-recommended LDL-C levels after 18 month final visit or last available observation during follow up visits.	the outcome variable, LDL-C, will be presented with mean and standard deviation	LDL-C target after 18 month final visit
Secondary	1. Relative and absolute reduction of LDL-C with lipid lowering medications added during the observation period.	the outcome variable, LDL-C, will be presented with mean and standard deviation	The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture
Secondary	Proportion of patients not achieving recommended LDL-C level based on high risk inclusion sub-group (e.g. FH), co-morbid conditions (diabetes mellitus), baseline treatment or baseline lipid profile.	the outcome variable, LDL-C, will be presented with mean and standard deviation	The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture
Secondary	Proportion of patients not achieving recommended LDL-C level at each of the follow up visits according to physician responses as to why country specific recommendation for LDL-C lowering opportunities was not followed.	the outcome variable, LDL-C, will be presented with mean and standard deviation	The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture
Secondary	Proportion of patients achieving LDL-C and non-HDL level across participating countries.	the outcome variable, LDL-C, will be presented with mean and standard deviation	The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture