Peripheral Arterial Insufficiency Associated With HIV/AIDS (AIHIV)

Prevalence and Risk Factors of Arterial Insufficiency in Patients 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.

Study Overview

• Status: Completed
• Conditions: Acquired Immunodeficiency Syndrome; HIV; Arterial Insufficiency
• Intervention / Treatment: Procedure: Ankle-Brachial index

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.

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• Mexico
  • D.F., Mexico
    • MExico city, D.F., Mexico, Mexico, 14000
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: Ankle-Brachial index; The only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial insufficiency	Arterial insufficiency is measured by Ankle / brachial index described as ABI<0.9 or ABI >1.2	1 time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	Male or Female	1 time
Age	Number of years	1 time
Diabetes mellitus	Defined as diagnosis in previous notes in the file or use of oral hypoglycemic agents.	1 time
Hypercholesterolemia	Defined as the last digit of C-LDL in serum of the patient, which is more than 150 mg / dL.	1 time
Hypertriglyceridemia	Defined as the last digit of the patient's serum triglycerides, which is greater than 200 mg / dL.	1 time
Hypoalphalipoproteinemia	Defined as the last digit of HDL-C in patient serum, which is less than 50 mg / dL.	1 time
Hypertension (High blood pressure)	Defined as diagnosis in previous notes or use of antihypertensives.	1 time
Ischemic heart disease	Defined as previous heart attack.	1 time
Stroke	Defined as previous diagnosis in the record.	1 time
Smoking	Smoking yes or no.	1 time
Smoking index	Smoking index defined as the number of cigarettes smoked per day by the number of years of smoking divided by 20.	1 time
Drug abuse	Defined as use or history of use of drugs of abuse investigated during the interview	1 time
AIDS	Defined as confirmatory serologic diagnosis of HIV associated with AIDS-defining illnesses	1 time
Diagnostic Time of HIV	Defined as the time interval in months from diagnosis of HIV to interview for the research protocol.	1 time
Viral Load	Defined as the last number of copies of certain virus in patient serum in the record.	1 time
CD4	Defined as the final determination of number of CD4 in serum.	1 time
HAART (Highly active anti-retroviral therapy)	Defined as use of at least one drug with anti-retroviral activity.	1 time
Time HAART	Defined as a period in months	1 TIME

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV	Defined as confirmatory serological diagnosis of HIV (ELISA + Western Blot)	1 time

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Investigators: Principal Investigator: Carlos A. Hinojosa, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Principal Investigator: Ana Elsa Núñez Salgado, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Study Chair: Laura Jael del C. Ortiz López, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Study Chair: Jaime Omar Herrera Cáceres, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Study Chair: Brenda E. Crabtree Ramirez, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Study Chair: Juan Sierra Madero, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 12, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Atherosclerosis; Human Immunodeficiency Virus; HAART; Arterial Insufficiency; Ankle-brachial index
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: InstitutoNCMNSZ-CIIBH693