Clinical trial NCT02264509: Peripheral Arterial Insufficiency Associated With HIV/AIDS
Official title: Prevalence and Risk Factors of Arterial Insufficiency in Patients With HIV / AIDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Insufficiency
Acquired Immunodeficiency Syndrome
HIV
Keywords: Arterial Insufficiency
Human Immunodeficiency Virus
Atherosclerosis
Ankle-brachial index
HAART
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The 206 patients will be randomly selected from the cohort HIV / AIDS INCMNSZ, which have confirmed diagnosis of the disease and wish to participate in the study, without a disease that put life in imminent danger.

Brief summary: The purpose of this study is to determine the risk factors associated with the occurrence of arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this disease. The estimated prevalence is 10%, similar to that reported in the general population.

Detailed description: A case study nested in a cohort of patients with HIV / AIDS at Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, with a cohort of 1500 patients , a sample size of 206 individuals was calculated. Data collection was performed in a prospective cross shape.

During the interview, written informed consent for inclusion in the study, along with a standard query of vascular surgery in which the patient's history as well as cardiovascular risk factors. Also, a vascular physical examination including palpation of pulses in upper and lower extremities (brachial, radial, ulnar, femoral, popliteal, posterior tibial and dorsalis pedis), femoral murmurs search and determining ankle / brachial indexes with a standardized method.

In determining the ABI was counted with a Doppler ultrasound 8 mHz, transducer gel and a sleeve for manual measurement of blood pressure, 20% longer than the largest diameter of the arm circumference.

If the patient is diagnosed with, symptomatic or asymptomatic arterial insufficiency, ABI measurements were performed at rest and effort, plus pressure index finger-arm or plethysmography. Patients with altered rates were followed in vascular surgery care.

The data were recorded in a single database unique protected by password. The results were analyzed using the statistical program STATA v 9.0.

Eligibility criteria: Inclusion Criteria:

* Patients with HIV / AIDS are included in active consultation of Infectious Diseases INCMNSZ and sign informed consent.

Exclusion Criteria:

* Patients who do not wish to participate in the study and those who did not complete their interview and vascular physical examination.

Primary outcomes:
measure: Arterial insufficiency
timeFrame: 1 time
Secondary outcomes:
measure: Gender
timeFrame: 1 time
measure: Age
timeFrame: 1 time
measure: Diabetes mellitus
timeFrame: 1 time
measure: Hypercholesterolemia
timeFrame: 1 time
measure: Hypertriglyceridemia
timeFrame: 1 time
measure: Hypoalphalipoproteinemia
timeFrame: 1 time
measure: Hypertension (High blood pressure)
timeFrame: 1 time
measure: Ischemic heart disease
timeFrame: 1 time
measure: Stroke
timeFrame: 1 time
measure: Smoking
timeFrame: 1 time
measure: Smoking index
timeFrame: 1 time
measure: Drug abuse
timeFrame: 1 time
measure: AIDS
timeFrame: 1 time
measure: Diagnostic Time of HIV
timeFrame: 1 time
measure: Viral Load
timeFrame: 1 time
measure: CD4
timeFrame: 1 time
measure: HAART (Highly active anti-retroviral therapy)
timeFrame: 1 time
measure: Time HAART
timeFrame: 1 TIME
Other outcomes:
measure: HIV
timeFrame: 1 time
Locations:
city: MExico city
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: D.F., Mexico
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Carlos A. Hinojosa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Ana Elsa Núñez Salgado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Laura Jael del C. Ortiz López, MD
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Jaime Omar Herrera Cáceres, MD
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Brenda E. Crabtree Ramirez, MD
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Juan Sierra Madero, MD
role: STUDY_CHAIR
References:
citation: Hinojosa CA, Nunez-Salgado AE, Anaya-Ayala JE, Laparra-Escareno H, Ortiz-Lopez LJ, Herrera-Caceres JO, Crabtree-Ramirez BE, Sierra-Madero JG. Prevalence and variables associated with an abnormal ankle-brachial index among patients with human immunodeficiency virus/acquired immunodeficiency syndrome. Vascular. 2018 Oct;26(5):540-546. doi: 10.1177/1708538118770542. Epub 2018 Apr 13.