- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02264509
Peripheral Arterial Insufficiency Associated With HIV/AIDS (AIHIV)
Prevalence and Risk Factors of Arterial Insufficiency in Patients With HIV / AIDS
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
D.F., Mexico
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MExico city, D.F., Mexico, 멕시코, 14000
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Arterial insufficiency
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gender
기간: 1 time
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Male or Female
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1 time
|
|
Age
기간: 1 time
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Number of years
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1 time
|
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Diabetes mellitus
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 1 time
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Defined as previous heart attack.
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1 time
|
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Stroke
기간: 1 time
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Defined as previous diagnosis in the record.
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1 time
|
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Smoking
기간: 1 time
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Smoking yes or no.
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1 time
|
|
Smoking index
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 1 TIME
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Defined as a period in months
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1 TIME
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
HIV
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Carlos A. Hinojosa, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- 수석 연구원: Ana Elsa Núñez Salgado, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- 연구 의자: Laura Jael del C. Ortiz López, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- 연구 의자: Jaime Omar Herrera Cáceres, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- 연구 의자: Brenda E. Crabtree Ramirez, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- 연구 의자: Juan Sierra Madero, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- InstitutoNCMNSZ-CIIBH693
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