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Completed

NCT Number: NCT02264509

Peripheral Arterial Insufficiency Associated With HIV/AIDS

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ankle-Brachial index

Procedure

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

Primary outcomes

  1. Arterial insufficiency

    Time frame: 1 time

    Arterial insufficiency is measured by Ankle / brachial index described as ABI<0.9 or ABI >1.2

Secondary outcomes

  1. Gender

    Time frame: 1 time

    Male or Female

  2. Age

    Time frame: 1 time

    Number of years

  3. Diabetes mellitus

    Time frame: 1 time

    Defined as diagnosis in previous notes in the file or use of oral hypoglycemic agents.

  4. Hypercholesterolemia

    Time frame: 1 time

    Defined as the last digit of C-LDL in serum of the patient, which is more than 150 mg / dL.

  5. Hypertriglyceridemia

    Time frame: 1 time

    Defined as the last digit of the patient's serum triglycerides, which is greater than 200 mg / dL.

  6. Hypoalphalipoproteinemia

    Time frame: 1 time

    Defined as the last digit of HDL-C in patient serum, which is less than 50 mg / dL.

  7. Hypertension (High blood pressure)

    Time frame: 1 time

    Defined as diagnosis in previous notes or use of antihypertensives.

  8. Ischemic heart disease

    Time frame: 1 time

    Defined as previous heart attack.

  9. Stroke

    Time frame: 1 time

    Defined as previous diagnosis in the record.

  10. Smoking

    Time frame: 1 time

    Smoking yes or no.

  11. Smoking index

    Time frame: 1 time

    Smoking index defined as the number of cigarettes smoked per day by the number of years of smoking divided by 20.

  12. Drug abuse

    Time frame: 1 time

    Defined as use or history of use of drugs of abuse investigated during the interview

  13. AIDS

    Time frame: 1 time

    Defined as confirmatory serologic diagnosis of HIV associated with AIDS-defining illnesses

  14. Diagnostic Time of HIV

    Time frame: 1 time

    Defined as the time interval in months from diagnosis of HIV to interview for the research protocol.

  15. Viral Load

    Time frame: 1 time

    Defined as the last number of copies of certain virus in patient serum in the record.

  16. CD4

    Time frame: 1 time

    Defined as the final determination of number of CD4 in serum.

  17. HAART (Highly active anti-retroviral therapy)

    Time frame: 1 time

    Defined as use of at least one drug with anti-retroviral activity.

  18. Time HAART

    Time frame: 1 TIME

    Defined as a period in months

Other outcomes

  1. HIV

    Time frame: 1 time

    Defined as confirmatory serological diagnosis of HIV (ELISA + Western Blot)

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

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

Acronym: AIHIV

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 15, 2014
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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