Peripheral Arterial Insufficiency Associated With HIV/AIDS

NCT ID: NCT02264509

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Arterial Insufficiency Acquired Immunodeficiency Syndrome HIV

Keywords

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Arterial Insufficiency Human Immunodeficiency Virus Atherosclerosis Ankle-brachial index HAART

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arterial insufficiency and HIV

Of a cohort of 206 HIV patients will be randomly selected 206 for Ankle-brachial index to identify wich suffer symptomatic or asymptomatic arterial insufficiency

Ankle-Brachial index

Intervention Type PROCEDURE

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

Interventions

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Ankle-Brachial index

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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Carlos Hinojosa

subdirector of clinical research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos A. Hinojosa, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Ana Elsa Núñez Salgado, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Laura Jael del C. Ortiz López, MD

Role: STUDY_CHAIR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Jaime Omar Herrera Cáceres, MD

Role: STUDY_CHAIR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brenda E. Crabtree Ramirez, MD

Role: STUDY_CHAIR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Juan Sierra Madero, MD

Role: STUDY_CHAIR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, D.f., Mexico, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type DERIVED
PMID: 29649953 (View on PubMed)

Other Identifiers

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InstitutoNCMNSZ-CIIBH693

Identifier Type: -

Identifier Source: org_study_id