ClinicalTrials.gg
CompletedNCT03861533GOAL QuERIUpdated Aug 22, 2024

GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL

An observational study in Dyslipidemia, sponsored by Dr. Anatoly Langer. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Dr. Anatoly Langer · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,422
Ages
18 Years and older
Sex
All
01

Study 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..
Read the 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.

02

Conditions studied

  • Dyslipidemia

Browse trials for

03

In context

Dyslipidemias

1,101 studies on the registry are indexed under Dyslipidemias; 161 are open to participants now.

This study's enrollment of 2,422 is above the median of 600 across 212 observational studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

This is the only study on the registry with Dr. Anatoly Langer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

GOAL International enrolling approximately 2500 patients with clinical vascular disease or familial hypercholesterolemia (FH) and LDL-C > 2.0 mmol/L (77 mg/dl) despite maximally tolerated statin therapy. As part of an interactive knowledge translation component, physicians are asked to indicate their next steps in lowering of LDL-C and are then asked whether they will be following the guidelines and if not why not.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Current treatment with PCSK9 inhibitor
  2. Current participation in investigational study
  3. Prior participation in the GOAL program
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,422 participants (actual)
Target follow-up
36 Months
Patient registry
Yes

Interventions

  • Othersurvey

    Cross-Reference

    Also known as: cross-sectional study without specific intervention

06

What researchers measure

Primary outcomes

  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.

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

    Time frame: LDL-C target after 18 month final visit

Secondary outcomes

  1. 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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  4. 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

    Time frame: 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

07

Study locations

4 sites
  • Sabah Hosptial
    Kuwait City, Kuwait
  • Centro de Estudios Clínicos de Querétaro (CECLIQ)
    Querétaro City, Querétaro, Mexico
  • King Fahd Military Medical Complex
    Dhahran, 31932, Saudi Arabia
  • Cleveland Clinic
    Abu Dhabi, United Arab Emirates
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03861533
Lead sponsor
Dr. Anatoly Langer
Collaborators
Amgen
Responsible party
Dr. Anatoly Langer (MD, M.Sc., FRCP (C), FACC, Canadian Heart Research Centre) — Sponsor-investigator
First posted
Mar 4, 2019
Start date
Apr 1, 2019
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Aug 22, 2024

Study contacts

Anatoly Langer, MD, M.Sc, FRCP(C,) FACC
study chair · Canadian Heart Rersearch Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion