Mexican Registry of Dyslipidemia in Patients at High Risk and Very High Risk of Atherosclerotic Cardiovascular

NCT05542719 | Unknown DMC

• 1 other identifier: R-2021-785-103
• Study Type: observational
• Target: 13,166
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Atherosclerotic cardiovascular disease (ACVD) comprising coronary disease, cerebrovascular disease, peripheral artery disease, and aortic atherosclerosis caused 8.9 million deaths worldwide according to reports submitted by the World Health Organization during 2019, the development and progression of atherosclerosis is favored in the presence of modifiable risk factors such as dyslipidemia. In Mexico, during the period from December 29, 2019, to August 29, 2020, 141,873 deaths from heart disease were reported, even above the 108,658 deaths from SARS COV2 in the same time period. Although it is known that the Mexican mestizo population is susceptible to certain metabolic lipid disorders related to genetic variants, the frequency of dyslipidemia in patients with high cardiovascular risk is unknown to date and may be responsible for this increase. On the other hand, it has been shown that lowering LDL-C levels in this population by means of the pharmacological or dietary treatment stated the current guidelines, decreases chance of death, heart failure, angina, re-infarction or need for coronary revascularization; however, there are still patients not achieving treatment goals. Consequently, it is suggested that through the implementation and correct use of technological tools it is possible to increase efficiency in the medical follow-up of patients, allowing for appropriate lipid levels, like other chronic degenerative diseases such as diabetes and systemic arterial hypertension. Objective. To describe the frequency of dyslipidemias in high-risk and very high-risk patients with atherosclerotic cardiovascular disease, who are IMSS beneficiaries, and to analyze the impact of using an application to achieve dyslipidemia treatment goals at one-year follow-up. Hypothesis For the National Register: Not required since the main objective is to carry out a national register of dyslipidemias. For the use of the application: Null hypothesis: The use of the application does not change the frequency of patients with high and extremely high atherosclerotic cardiovascular risk who achieve the goals of dyslipidemia treatment during one year of follow-up.

Conditions

Secondary Prevention; Cardiovascular Disease With Mention of Arteriosclerosis; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• National Register

  Frequency of dyslipidemia according to the geographic region of the country.

  1 year

• use of the application

  Usefulness of the application in achieving dyslipidemia treatment goals in patients with high and extremely high cardiovascular risk

  2 years

Study Arms (1)

frequency of dyslipidemias

To describe the frequency of dyslipidemias in high-risk and very high-risk patients with atherosclerotic cardiovascular disease and analyze the impact of using an application to achieve dyslipidemia treatment goals at one-year follow-up.

Other: application

Interventions

application OTHER

Through the application, determine if the patient is out of LDL-C goals for referral and treatment review. Show the usefulness of the application in achieving dyslipidemia treatment goals in patients with high and extremely high cardiovascular risk

frequency of dyslipidemias

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who attend outpatient service of family medicine, internal medicine, cardiology, or endocrinology of hospitals of first, second or third level of care of the Mexican Institute of Social Security and who meet the definition of elevated risk or extremely elevated risk of atherosclerotic cardiovascular disease.

You may qualify if:

• Adults, over 18 years old, Both biological sexes, And having any of the following characteristics
• Recurring atherosclerotic disease (2 or more events of atherosclerotic cardiovascular disease)
• Atherosclerotic cardiovascular disease plus
• type 1 or type 2 diabetes mellitus with over 20 years of evolution,
• Chronic renal failure with glomerular filtration rate lower than 30 mL/min or receiving dialysis or hemodialysis.
• History of familial hypercholesterolemia in 1° or 2° degree.
• At least one of the following factors
• Cholesterol ≥310 mg/dL (8 mmol/L) and/or LDL-C ≥190mg/dL and/or blood pressure ≥180/110 mmHg.
• Familial hypercholesterolemia at 1° or 2° without other risk factors.
• Diabetes mellitus without damage to target organ or more than 10 years of evolution plus another risk factor such as hypertension, dyslipidemia, or active smoking
• Chronic renal failure with glomerular filtration between 30 and 59 mL/min.

You may not qualify if:

• Patients with acute coronary syndrome in the last two months
• Patients requiring hospitalization.
• Pregnant or lactating women.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Amgen: collaborator

Study Sites (1)

Umae Cmn T1

León, Guanajuato, Mexico

RECRUITING

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Martha A Hernandez, Gonzalez

  CIS Mexico

  PRINCIPAL INVESTIGATOR

• Juan P Fernandez, Hernandez

  CIS Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan P Fernandez, Hernandez

CONTACT

4772725453; jp.fernandezhernandez@ugto.mx

Martha A Hernandez, Gonzalez

CONTACT

4771567649; martha.hernandezg@imss.gob.mx

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of health research division Centro Medico Nacional Bajio Umae T1 Leon Guanajuato

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 15, 2022
• Study Start: August 4, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

ME (1)