Substudy - Evaluation of Patients With Iliac Vein Thrombosis

Sponsor

Cardioangiologisches Centrum Bethanien (Other)

Overall Status

Completed

CT.gov ID

NCT03148548

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with previous diagnosis of iliac vein thrombosis are enrolled in this registry. Using standardized questionnaire, clinical data detailing venous thromboembolism and contributing VTE risk factors are recorded. Results of technical and laboratory investigations including screening of thrombophilic disorders were additionally entered into the database.

Condition or Disease	Intervention/Treatment	Phase
Iliac Vein Thrombosis	Genetic: thrombophilia screening

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

85 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Iliofemoral Thrombosis and Postthrombotic Syndrome: Registration and Analysis Within the Frankfurt Thrombophilia Registry

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients with iliofermoral thrombosis without rekanalisation subjects with proven iliofemoral thrombosis (V. cava-aplasia, pelvic vein thrombosis, VTE) which was proven by objective methods such as Duplex sonography, CT/MRT, phlebography and who did not undergo recanalisation	Genetic: thrombophilia screening genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;
Patients with ilifermoral thrombosis with rekanalisation subjects with proven iliofemoral thrombosis (V. cava-aplasia, pelvic vein thrombosis, VTE) which was proven by objective methods such as Duplex sonography, CT/MRT, phlebography and who did undergo recanalisation	Genetic: thrombophilia screening genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;

Arm

Intervention/Treatment

Patients with iliofermoral thrombosis without rekanalisation

subjects with proven iliofemoral thrombosis (V. cava-aplasia, pelvic vein thrombosis, VTE) which was proven by objective methods such as Duplex sonography, CT/MRT, phlebography and who did not undergo recanalisation

Genetic: thrombophilia screening

genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;

Patients with ilifermoral thrombosis with rekanalisation

Genetic: thrombophilia screening

genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;

Outcome Measures

Primary Outcome Measures

Incidence and severity of postthrombotic Syndrome after iliofemoral thrombosis [up to 20 years after occurrence of iliofemoral thrombosis]
The incidence and severity of postthrombotic Syndrome will be measured by te VILALLTA-Score

Secondary Outcome Measures

Distribution of gender in Iliofemoral thrombosis [since 1996]
Distribution of gender (man or woman)
Distribution of affected side in Iliofemoral thrombosis [since 1996]
distribution of affected side (left or right side)
Disease-specific quality of life instrument for use in venous diseases of the leg (VEINES-QOL) [1 year]
A quality of life questionaire comprises 25 items that quantify disease effect on quality of life
Incidence of venous claudication [1 year]
Walking distance on treadmill

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years
subjects with iliofermoral thrombosis, which has been proven by objective measurements (Duplex sonography, phlebography, CT/MRT) later than 1996