Arterial InsufficiencyAIHIVNCT02264509
Peripheral Arterial Insufficiency Associated With HIV/AIDS
An observational study of Arterial Insufficiency and Acquired Immunodeficiency Syndrome, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Arterial Insufficiency, Acquired Immunodeficiency Syndrome, HIV
- What is being tested?
- Ankle-Brachial index
- Type of treatment
- Surgery or procedure
- How many people
- 206 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2014to Dec 2014
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with HIV / AIDS are included in active consultation of Infectious Diseases INCMNSZ and sign informed consent.
Who cannot join
- Patients who do not wish to participate in the study and those who did not complete their interview and vascular physical examination.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, D.f., Mexico, 14000
About this study
Official title: 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.
Read the 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.
- Being tested
- Ankle-Brachial index
- Keywords
- Arterial Insufficiency, Human Immunodeficiency Virus, Atherosclerosis, Ankle-brachial index, HAART
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle-Brachial indexProcedure or surgery
The only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Ankle-Brachial index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial insufficiency
Arterial insufficiency is measured by Ankle / brachial index described as ABI<0.9 or ABI >1.2
Measured: 1 time
Secondary outcomes (18)
Gender
Male or Female
Measured: 1 time
Age
Number of years
Measured: 1 time
Diabetes mellitus
Defined as diagnosis in previous notes in the file or use of oral hypoglycemic agents.
Measured: 1 time
Hypercholesterolemia
Defined as the last digit of C-LDL in serum of the patient, which is more than 150 mg / dL.
Measured: 1 time
Hypertriglyceridemia
Defined as the last digit of the patient's serum triglycerides, which is greater than 200 mg / dL.
Measured: 1 time
Hypoalphalipoproteinemia
Defined as the last digit of HDL-C in patient serum, which is less than 50 mg / dL.
Measured: 1 time
Hypertension (High blood pressure)
Defined as diagnosis in previous notes or use of antihypertensives.
Measured: 1 time
Ischemic heart disease
Defined as previous heart attack.
Measured: 1 time
Stroke
Defined as previous diagnosis in the record.
Measured: 1 time
Smoking
Smoking yes or no.
Measured: 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.
Measured: 1 time
Drug abuse
Defined as use or history of use of drugs of abuse investigated during the interview
Measured: 1 time
AIDS
Defined as confirmatory serologic diagnosis of HIV associated with AIDS-defining illnesses
Measured: 1 time
Diagnostic Time of HIV
Defined as the time interval in months from diagnosis of HIV to interview for the research protocol.
Measured: 1 time
Viral Load
Defined as the last number of copies of certain virus in patient serum in the record.
Measured: 1 time
CD4
Defined as the final determination of number of CD4 in serum.
Measured: 1 time
HAART (Highly active anti-retroviral therapy)
Defined as use of at least one drug with anti-retroviral activity.
Measured: 1 time
Time HAART
Defined as a period in months
Measured: 1 TIME
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Hinojosa, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Carlos A. Hinojosa, MD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranAna Elsa Núñez Salgado, MD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranLaura Jael del C. Ortiz López, MD, Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranJaime Omar Herrera Cáceres, MD, Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranBrenda E. Crabtree Ramirez, MD, Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranJuan Sierra Madero, MD, Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264509
- Sponsor's protocol ID
- InstitutoNCMNSZ-CIIBH693
- Acronym
- AIHIV
- Status last verified
- Jan 2016
- First submitted
- 12 Sep 2014
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29649953
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Arterial Insufficiency in Patients With HIV / AIDS
- ClinicalTrials.gov ID
- NCT02264509
- Acronym / sponsor ID
- AIHIV / InstitutoNCMNSZ-CIIBH693
- Keywords
- Arterial Insufficiency, Human Immunodeficiency Virus, Atherosclerosis, Ankle-brachial index, HAART
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arterial insufficiency and HIV | – | Procedure: Ankle-Brachial indexOf a cohort of 206 HIV patients will be randomly selected 206 for Ankle-brachial index to identify wich suffer symptomatic or asymptomatic arterial insufficiency |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with HIV / AIDS are included in active consultation of Infectious Diseases INCMNSZ and sign informed consent.
Key exclusion criteria (1 listed)
- Patients who do not wish to participate in the study and those who did not complete their interview and vascular physical examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle-Brachial indexThe only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency. | Procedure or surgery | Arterial insufficiency and HIV |
Primary outcome
Arterial insufficiency
Time frame: 1 time
Arterial insufficiency is measured by Ankle / brachial index described as ABI<0.9 or ABI >1.2
18 secondary outcomes
Gender
Time frame: 1 time
Age
Time frame: 1 time
Diabetes mellitus
Time frame: 1 time
Hypercholesterolemia
Time frame: 1 time
Hypertriglyceridemia
Time frame: 1 time
Hypoalphalipoproteinemia
Time frame: 1 time
Hypertension (High blood pressure)
Time frame: 1 time
Ischemic heart disease
Time frame: 1 time
Stroke
Time frame: 1 time
Smoking
Time frame: 1 time
Smoking index
Time frame: 1 time
Drug abuse
Time frame: 1 time
AIDS
Time frame: 1 time
Diagnostic Time of HIV
Time frame: 1 time
Viral Load
Time frame: 1 time
CD4
Time frame: 1 time
HAART (Highly active anti-retroviral therapy)
Time frame: 1 time
Time HAART
Time frame: 1 TIME
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Derived from this study: PubMed 29649953Hinojosa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A. Hinojosa, MD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Ana Elsa Núñez Salgado, MD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Laura Jael del C. Ortiz López, MD study chair
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Insufficiency and Acquired Immunodeficiency Syndrome, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial insufficiency (time frame: 1 time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02264509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016; AzTrials last refreshed its copy on 31 Oct 2026.