Dyslipidemias Clinical Trial
— REMEXDISOfficial title:
Mexican Registry of Dyslipidemia in Patients at High and Very High Risk of Atherosclerotic Cardiovascular Disease and the Use of an Application to Achieve Dyslipidemic Treatment Goals - REMEXDIS-IMSS
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.
Status | Recruiting |
Enrollment | 13166 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults, over 18 years old, Both biological sexes, And having any of the following characteristics 1. Recurring atherosclerotic disease (2 or more events of atherosclerotic cardiovascular disease) 2. 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. 3. 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. Exclusion Criteria: - Patients with acute coronary syndrome in the last two months - Patients requiring hospitalization. - Pregnant or lactating women. |
Country | Name | City | State |
---|---|---|---|
Mexico | Umae Cmn T1 | Leon | Guanajuato |
Lead Sponsor | Collaborator |
---|---|
Coordinación de Investigación en Salud, Mexico | Amgen |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | National Register | Frequency of dyslipidemia according to the geographic region of the country. | 1 year | |
Primary | use of the application | Usefulness of the application in achieving dyslipidemia treatment goals in patients with high and extremely high cardiovascular risk | 2 years |
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