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Peripheral Arterial Insufficiency Associated With HIV/AIDS

Prevalence and Risk Factors of Arterial Insufficiency in Patients With HIV / AIDS

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02264509
Acronym
AIHIV
Enrollment
206
Registered
2014-10-15
Start date
2014-09-30
Completion date
2014-12-31
Last updated
2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Insufficiency, Acquired Immunodeficiency Syndrome, HIV

Keywords

Arterial Insufficiency, Human Immunodeficiency Virus, Atherosclerosis, Ankle-brachial index, HAART

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.

Interventions

The only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency.

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Arterial insufficiency1 timeArterial insufficiency is measured by Ankle / brachial index described as ABI\<0.9 or ABI \>1.2

Secondary

MeasureTime frameDescription
Gender1 timeMale or Female
Age1 timeNumber of years
Diabetes mellitus1 timeDefined as diagnosis in previous notes in the file or use of oral hypoglycemic agents.
Hypercholesterolemia1 timeDefined as the last digit of C-LDL in serum of the patient, which is more than 150 mg / dL.
Hypertriglyceridemia1 timeDefined as the last digit of the patient's serum triglycerides, which is greater than 200 mg / dL.
Hypoalphalipoproteinemia1 timeDefined as the last digit of HDL-C in patient serum, which is less than 50 mg / dL.
Hypertension (High blood pressure)1 timeDefined as diagnosis in previous notes or use of antihypertensives.
Ischemic heart disease1 timeDefined as previous heart attack.
Stroke1 timeDefined as previous diagnosis in the record.
Smoking index1 timeSmoking index defined as the number of cigarettes smoked per day by the number of years of smoking divided by 20.
Drug abuse1 timeDefined as use or history of use of drugs of abuse investigated during the interview
AIDS1 timeDefined as confirmatory serologic diagnosis of HIV associated with AIDS-defining illnesses
Diagnostic Time of HIV1 timeDefined as the time interval in months from diagnosis of HIV to interview for the research protocol.
Viral Load1 timeDefined as the last number of copies of certain virus in patient serum in the record.
CD41 timeDefined as the final determination of number of CD4 in serum.
HAART (Highly active anti-retroviral therapy)1 timeDefined as use of at least one drug with anti-retroviral activity.
Time HAART1 TIMEDefined as a period in months
Smoking1 timeSmoking yes or no.

Other

MeasureTime frameDescription
HIV1 timeDefined as confirmatory serological diagnosis of HIV (ELISA + Western Blot)

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026