## Protocol Section
### Identification Module
**NCT ID:** NCT00508079

**Brief Title:** Evaluating the Occurence of New and Progression of Existing Peripheral Venous Disease in Leg Veins

**Official Title:** Incidence and Progression of Peripheral Venous Disease

#### Organization Study ID Info
**ID:** 1389
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Diego
#### Secondary ID Infos
**ID:** R01HL084229-01A1
**Link:** https://reporter.nih.gov/quickSearch/R01HL084229-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2011-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-07-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-07-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-01

**Type:** ACTUAL

#### Start Date
**Date:** 2007-07

**Status Verified Date:** 2013-07

#### Study First Post Date
**Date:** 2007-07-27
**Type:** ESTIMATED
**Study First Submit Date:** 2007-07-25
**Study First Submit QC Date:** 2007-07-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Heart, Lung, and Blood Institute (NHLBI)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, San Diego

#### Responsible Party

**Investigator Affiliation:** University of California, San Diego

**Investigator Full Name:** Dr. Michael H. Criqui

**Investigator Title:** Distinguished Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Peripheral venous disease occurs when a vein becomes damaged or blocked. It can occur almost anywhere in the body, but is most common in the arms and legs. This study will examine people who participated in a previous venous disease study to evaluate changes in leg veins and venous disease status over a period of 11 years.

**Detailed Description:** Peripheral venous disease is a general term for damage, defects, or blockage that occurs in the peripheral veins, which carry blood from the hands and feet back to the heart to receive oxygen. The most common cause of peripheral venous disease is a blood clot that blocks a vein. Varicose veins, which are swollen blood vessels near the surface of the skin, and chronic venous insufficiency, a condition in which blood in the leg veins does not drain properly, are two other common types of peripheral venous disease. From 1996 to 2000, the San Diego Population Study (SDPS) evaluated a group of individuals to gather information on the prevalence of venous disease. This current study will re-evaluate the SDPS participants to document changes that have occurred in their leg veins over the past 11 years, including any new venous disease and any progression of existing venous disease. Study researchers will also evaluate how venous disease relates to risk factors, symptoms, and quality of life issues.

This study will enroll people who participated in the SDPS study. Each participant will attend one study visit. Study staff will conduct a 1-hour interview with each participant to collect information on their medical history, disease-related symptoms, risk factors for venous disease, family health history, health habits, and quality of life. Blood collection will occur, participant's leg veins will be examined and photographed, and blood flow in the legs will be measured with an ultrasound.

### Conditions Module

**Conditions:**

- Peripheral Vascular Diseases

**Keywords:**

- Venous Disease

- Varicose Veins

- Chronic Venous Insufficiency

- PAD

### Design Module

#### Bio Spec

**Description:** Whole blood, serum, plasma

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

#### Enrollment Info

**Count:** 1103

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Incident Venous Disease

**Time Frame:** Since previous visit (approximately 11 years)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participated in the SDPS study

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Previous participants from the San Diego Population Study

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** La Jolla

**Country:** United States

**Facility:** University of California San Diego

**State:** California

**Zip:** 92093

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Diego

**Name:** Michael H. Criqui, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000050197

- Term: Atherosclerosis

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17400

- Name: Vascular Diseases

- Relevance: HIGH

- As Found: Vascular Disease

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: HIGH

- As Found: Peripheral Vascular Disease

- ID: M18894

- Name: Peripheral Vascular Diseases

- Relevance: HIGH

- As Found: Peripheral Vascular Disease

- ID: M17435

- Name: Venous Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M20559

- Name: Disease Progression

- Relevance: LOW

- As Found: Unknown

- ID: M17396

- Name: Varicose Veins

- Relevance: LOW

- As Found: Unknown

- ID: M26188

- Name: Atherosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014652

- Term: Vascular Diseases

- ID: D000016491

- Term: Peripheral Vascular Diseases

- ID: D000058729

- Term: Peripheral Arterial Disease

### Misc Info Module

- Version Holder: 2024-05-24
