NCT02264509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

September 12, 2014

Last Update Submit

January 28, 2016

Conditions

Arterial InsufficiencyAcquired Immunodeficiency SyndromeHIV

Keywords

Arterial InsufficiencyHuman Immunodeficiency VirusAtherosclerosisAnkle-brachial indexHAART

Outcome Measures

Primary Outcomes (1)

  • Arterial insufficiency

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

    1 time

Secondary Outcomes (18)

  • Gender

    1 time

  • Age

    1 time

  • Diabetes mellitus

    1 time

  • Hypercholesterolemia

    1 time

  • Hypertriglyceridemia

    1 time

  • +13 more secondary outcomes

Other Outcomes (1)

  • HIV

    1 time

Study Arms (1)

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

Interventions

Ankle-Brachial indexPROCEDURE

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

Arterial insufficiency and HIV

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients with HIV / AIDS are included in active consultation of Infectious Diseases INCMNSZ and sign informed consent.

You may not qualify if:

  • Patients who do not wish to participate in the study and those who did not complete their interview and vascular physical examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, D.f., Mexico, 14000, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 29649953DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeAtherosclerosis

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
subdirector of clinical research

Study Record Dates

First Submitted

September 12, 2014

First Posted

October 15, 2014

Study Start

September 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

ME(1)