Peripheral Arterial Insufficiency Associated With HIV/AIDS

HIV Clinical Trial

— AIHIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02264509
• Other study ID #: InstitutoNCMNSZ-CIIBH693
• Status: Completed
• Phase: N/A
• First received: September 12, 2014
• Last updated: January 28, 2016
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Arterial Insufficiency
• HIV
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Procedure:
• Ankle-Brachial index
The only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	MExico city	D.F., Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HIV	Defined as confirmatory serological diagnosis of HIV (ELISA + Western Blot)	1 time	No
Primary	Arterial insufficiency	Arterial insufficiency is measured by Ankle / brachial index described as ABI<0.9 or ABI >1.2	1 time	No
Secondary	Gender	Male or Female	1 time	No
Secondary	Age	Number of years	1 time	No
Secondary	Diabetes mellitus	Defined as diagnosis in previous notes in the file or use of oral hypoglycemic agents.	1 time	No
Secondary	Hypercholesterolemia	Defined as the last digit of C-LDL in serum of the patient, which is more than 150 mg / dL.	1 time	No
Secondary	Hypertriglyceridemia	Defined as the last digit of the patient's serum triglycerides, which is greater than 200 mg / dL.	1 time	No
Secondary	Hypoalphalipoproteinemia	Defined as the last digit of HDL-C in patient serum, which is less than 50 mg / dL.	1 time	No
Secondary	Hypertension (High blood pressure)	Defined as diagnosis in previous notes or use of antihypertensives.	1 time	No
Secondary	Ischemic heart disease	Defined as previous heart attack.	1 time	No
Secondary	Stroke	Defined as previous diagnosis in the record.	1 time	No
Secondary	Smoking	Smoking yes or no.	1 time	No
Secondary	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	No
Secondary	Drug abuse	Defined as use or history of use of drugs of abuse investigated during the interview	1 time	No
Secondary	AIDS	Defined as confirmatory serologic diagnosis of HIV associated with AIDS-defining illnesses	1 time	No
Secondary	Diagnostic Time of HIV	Defined as the time interval in months from diagnosis of HIV to interview for the research protocol.	1 time	No
Secondary	Viral Load	Defined as the last number of copies of certain virus in patient serum in the record.	1 time	No
Secondary	CD4	Defined as the final determination of number of CD4 in serum.	1 time	No
Secondary	HAART (Highly active anti-retroviral therapy)	Defined as use of at least one drug with anti-retroviral activity.	1 time	No
Secondary	Time HAART	Defined as a period in months	1 TIME	No