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Peripheral Arterial Insufficiency Associated With HIV/AIDS (AIHIV)

28. januar 2016 opdateret af: Carlos Hinojosa, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

206

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 89 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Arterial insufficiency
Tidsramme: 1 time
Arterial insufficiency is measured by Ankle / brachial index described as ABI<0.9 or ABI >1.2
1 time

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HIV
Tidsramme: 1 time
Defined as confirmatory serological diagnosis of HIV (ELISA + Western Blot)
1 time

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Efterforskere

  • Ledende efterforsker: Carlos A. Hinojosa, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Ledende efterforsker: Ana Elsa Núñez Salgado, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Studiestol: Laura Jael del C. Ortiz López, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Studiestol: Jaime Omar Herrera Cáceres, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Studiestol: Brenda E. Crabtree Ramirez, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Studiestol: Juan Sierra Madero, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2014

Primær færdiggørelse (Faktiske)

1. november 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

12. september 2014

Først indsendt, der opfyldte QC-kriterier

9. oktober 2014

Først opslået (Skøn)

15. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • InstitutoNCMNSZ-CIIBH693

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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