NCT05296499

Brief Summary

Deep vein thrombosis (DVT) can cause long-term scarring and narrowing of veins. When there is extensive damage to the veins in the legs, groin or abdomen it can affect the way that blood is able to flow back up to the heart. Some patients are left with severe symptoms such as pain, leg swelling and ulcers, and have surgical treatment with nitinol stents to re-open the veins and relieve symptoms. The primary aim of this study is to investigate venous blood flow to the heart during exercise in patients with extensive damage to the veins in the groin and abdomen after DVT, and changes that happen after stenting.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

March 16, 2022

Last Update Submit

March 16, 2022

Conditions

Venous Thrombosis Deep (Limbs)Post Thrombotic Syndrome

Outcome Measures

Primary Outcomes (2)

  • VO2 max after stenting

    As determined by cardiopulmonary exercise testing

    6-8 weeks post surgery

  • Peak cardiac output during exercise

    as determined by exercise cardiac MRI

    6-8 weeks post surgery

Study Arms (4)

Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea

Baseline assessments Post-operative assessments if applicable

Diagnostic Test: Cardiopulmonary exercise test (CPET)Diagnostic Test: Exercise cardiac MRIOther: 6 minute walk testDiagnostic Test: Blood testsOther: Quality of life questionnairesOther: Repeat baseline assessmentsDiagnostic Test: MR venogram

Venous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoea

Baseline assessments Post-operative assessments if applicable

Diagnostic Test: Cardiopulmonary exercise test (CPET)Diagnostic Test: Exercise cardiac MRIOther: 6 minute walk testDiagnostic Test: Blood testsOther: Quality of life questionnairesOther: Repeat baseline assessmentsDiagnostic Test: MR venogram

Unilateral iliac venous outflow obstruction

Baseline assessments Post-operative assessments if applicable

Diagnostic Test: Cardiopulmonary exercise test (CPET)Diagnostic Test: Exercise cardiac MRIOther: 6 minute walk testDiagnostic Test: Blood testsOther: Quality of life questionnairesOther: Repeat baseline assessmentsDiagnostic Test: MR venogram

Age and sex matched controls

Baseline assessments

Diagnostic Test: Cardiopulmonary exercise test (CPET)Diagnostic Test: Exercise cardiac MRIOther: 6 minute walk testOther: Quality of life questionnairesOther: Repeat baseline assessments

Interventions

Cardiopulmonary exercise test (CPET)DIAGNOSTIC_TEST

Cardiopulmonary exercise testing using cycle ergonomenter

Age and sex matched controlsUnilateral iliac venous outflow obstructionVenous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoeaVenous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea
Exercise cardiac MRIDIAGNOSTIC_TEST

Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET

Age and sex matched controlsUnilateral iliac venous outflow obstructionVenous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoeaVenous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea
6 minute walk testOTHER

6MWT

Age and sex matched controlsUnilateral iliac venous outflow obstructionVenous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoeaVenous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea
Blood testsDIAGNOSTIC_TEST

FBC, U\&E, LFTS

Unilateral iliac venous outflow obstructionVenous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoeaVenous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea
Quality of life questionnairesOTHER

SF36, EQ5D, VEINES-QoL/Sym

Age and sex matched controlsUnilateral iliac venous outflow obstructionVenous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoeaVenous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea
Repeat baseline assessmentsOTHER

repeat baseline

Age and sex matched controlsUnilateral iliac venous outflow obstructionVenous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoeaVenous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea
MR venogramDIAGNOSTIC_TEST

MRI scan of venous system

Unilateral iliac venous outflow obstructionVenous outflow obstruction extending to inferior vena cava, not symptomatic with dyspnoeaVenous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with previous deep vein thrombosis /chronic outflow obstruction in the iliofemoral veins and inferior vena cava.

You may qualify if:

  • All groups:
  • \>16 years of age
  • \- Consent to participate in the research study and be willing to commit to study requirements, including completion of questionnaires and follow up visits.
  • Group 1:
  • Venous thrombosis/obstruction involving the inferior vena cava \>12 months ago.
  • Symptoms of exertional dyspnoea reported by patient.
  • Judged by the chief investigator as suitable for surgical intervention before recruitment to the study.
  • Agree to adhere to therapeutic anticoagulation after surgical intervention.
  • Group 2:
  • Venous thrombosis/obstruction involving the inferior vena cava \>12 months ago.
  • Under the clinical care of the deep venous service for surveillance of symptoms.
  • Group 3:
  • Unilateral Iliofemoral venous thrombosis /obstruction \>12 months ago.
  • Judged by the chief investigator as suitable for surgical intervention before recruitment to the study.
  • Agree to adhere to therapeutic anticoagulation after surgical intervention.

You may not qualify if:

  • All groups:
  • DVT or PE in last 12 months
  • Significant or untreated left sided heart disease (eg coronary artery disease, LV dysfunction, valvular abnormalities, congenital heart disease, chronic or paroxysmal arrhythmias)
  • Significant or untreated chronic lung disease (eg asthma, COPD, ILD)
  • Moderate to severe renal disease
  • Moderate to severe liver disease
  • Peripheral arterial disease
  • Significant neurological or musculoskeletal disease
  • Cognitive impairment or learning disabilities
  • Pregnant or planning to become pregnant in next 12 months
  • Active cancer (primary, metastatic or treated within last 6 months)
  • Life expectancy \< 2 years or chronic non-ambulatory status.
  • Any other contraindication to exercise.
  • Any contraindications to MRI scanning
  • Inability to provide informed consent or comply with study assessments (e.g. due to cognitive impairment, physical limitations or geographic distance).
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Venous ThrombosisPostthrombotic Syndrome

Interventions

Exercise TestHematologic Tests

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVenous Insufficiency

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesClinical Laboratory Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

March 25, 2022

Study Start

September 20, 2019

Primary Completion

October 20, 2022

Study Completion

April 20, 2023

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations

GB(1)