- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02264509
Peripheral Arterial Insufficiency Associated With HIV/AIDS (AIHIV)
Prevalence and Risk Factors of Arterial Insufficiency in Patients With HIV / AIDS
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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D.F., Mexico
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MExico city, D.F., Mexico, Mexico, 14000
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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
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The only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Arterial insufficiency
Tidsramme: 1 time
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Arterial insufficiency is measured by Ankle / brachial index described as ABI<0.9 or ABI >1.2
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1 time
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Gender
Tidsramme: 1 time
|
Male or Female
|
1 time
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Age
Tidsramme: 1 time
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Number of years
|
1 time
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Diabetes mellitus
Tidsramme: 1 time
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Defined as diagnosis in previous notes in the file or use of oral hypoglycemic agents.
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1 time
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Hypercholesterolemia
Tidsramme: 1 time
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Defined as the last digit of C-LDL in serum of the patient, which is more than 150 mg / dL.
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1 time
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Hypertriglyceridemia
Tidsramme: 1 time
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Defined as the last digit of the patient's serum triglycerides, which is greater than 200 mg / dL.
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1 time
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Hypoalphalipoproteinemia
Tidsramme: 1 time
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Defined as the last digit of HDL-C in patient serum, which is less than 50 mg / dL.
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1 time
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Hypertension (High blood pressure)
Tidsramme: 1 time
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Defined as diagnosis in previous notes or use of antihypertensives.
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1 time
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Ischemic heart disease
Tidsramme: 1 time
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Defined as previous heart attack.
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1 time
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Stroke
Tidsramme: 1 time
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Defined as previous diagnosis in the record.
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1 time
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Smoking
Tidsramme: 1 time
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Smoking yes or no.
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1 time
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Smoking index
Tidsramme: 1 time
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Smoking index defined as the number of cigarettes smoked per day by the number of years of smoking divided by 20.
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1 time
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Drug abuse
Tidsramme: 1 time
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Defined as use or history of use of drugs of abuse investigated during the interview
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1 time
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AIDS
Tidsramme: 1 time
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Defined as confirmatory serologic diagnosis of HIV associated with AIDS-defining illnesses
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1 time
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Diagnostic Time of HIV
Tidsramme: 1 time
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Defined as the time interval in months from diagnosis of HIV to interview for the research protocol.
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1 time
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Viral Load
Tidsramme: 1 time
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Defined as the last number of copies of certain virus in patient serum in the record.
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1 time
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CD4
Tidsramme: 1 time
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Defined as the final determination of number of CD4 in serum.
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1 time
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HAART (Highly active anti-retroviral therapy)
Tidsramme: 1 time
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Defined as use of at least one drug with anti-retroviral activity.
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1 time
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Time HAART
Tidsramme: 1 TIME
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Defined as a period in months
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1 TIME
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
HIV
Tidsramme: 1 time
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Defined as confirmatory serological diagnosis of HIV (ELISA + Western Blot)
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1 time
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Carlos A. Hinojosa, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Hovedetterforsker: 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
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
- Immunologiske mangelsyndromer
Andre studie-ID-numre
- InstitutoNCMNSZ-CIIBH693
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