GOAL QuERI: GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL

• Sponsor: Dr. Anatoly Langer (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03861533
• Collaborator: Amgen (Industry)
• Enrollment: 2,500
• Locations: 4
• Anticipated Duration (Months): 48
• Patients Per Site: 625
• Patients Per Site Per Month: 13

Study Details

Study Description

Brief 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..

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Other: survey

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 2500 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Guidelines Oriented Approach to Lipid Lowering Quality Enhancement Research Initiative (GOAL QuERI) International
• Actual Study Start Date: Apr 1, 2019
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Outcome Measures

Primary Outcome Measures

1. Proportion of patients achieving country specific guideline-recommended LDL-C levels after 18 month final visit or last available observation during follow up visits. [LDL-C target after 18 month final visit]

   the outcome variable, LDL-C, will be presented with mean and standard deviation

Secondary Outcome Measures

1. 1. Relative and absolute reduction of LDL-C with lipid lowering medications added during the observation period. [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]

   the outcome variable, LDL-C, will be presented with mean and standard deviation

2. 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 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]

   the outcome variable, LDL-C, will be presented with mean and standard deviation

3. 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 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]

   the outcome variable, LDL-C, will be presented with mean and standard deviation

4. Proportion of patients achieving LDL-C and non-HDL level across participating countries. [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]

   the outcome variable, LDL-C, will be presented with mean and standard deviation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sabah Hosptial	Kuwait		Kuwait
2	Centro de Estudios Clínicos de Querétaro (CECLIQ)	Querétaro	Qro	Mexico
3	King Fahd Military Medical Complex	Dhahran		Saudi Arabia	31932
4	Cleveland Clinic	Abu Dhabi		United Arab Emirates

Sponsors and Collaborators

• Dr. Anatoly Langer
• Amgen

Investigators

• Study Chair: Anatoly Langer, MD, M.Sc, FRCP(C,) FACC, Canadian Heart Rersearch Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Anatoly Langer, MD, M.Sc., FRCP (C), FACC, Canadian Heart Research Centre
• ClinicalTrials.gov Identifier: NCT03861533
• Other Study ID Numbers: CHRC2019-GOAL INT
• First Posted: Mar 4, 2019
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyslipidemias

Study Results

No Results Posted as of Mar 9, 2022