EXERT: Exercise Physiology After Thrombosis

Exercise Physiology After Thrombosis (EXERT): a Prospective Single Centre Cohort Study of Cardiovascular and Exercise Physiology in Patients With Previous Venous Thrombosis in the Inferior Vena Cava and Iliofemoral Veins.

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.

Study Overview

• Status: Recruiting
• Conditions: Post Thrombotic Syndrome; Venous Thrombosis Deep (Limbs)
• Intervention / Treatment: Diagnostic test: Cardiopulmonary exercise test (CPET); Diagnostic test: Exercise cardiac MRI; Other: 6 minute walk test; Diagnostic test: Blood tests; Other: Quality of life questionnaires; Other: Repeat baseline assessments; Diagnostic test: MR venogram

Detailed Description

Participants will have cardiopulmonary exercise testing, 6 minute walk test and basic blood tests to establish exercise tolerance and rule out other heart and lung conditions. Exercise cardiac MRI will be used to evaluate cardiac function during exercise. All participants will complete generic and disease specific quality of life questionnaires.

Participants who are having a stenting procedure will repeat assessments 6-8 weeks after surgery.

• Study Type: Observational
• Enrollment (Anticipated): 56

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guys and St Thomas' NHS Foundation Trust
    • Contact: Rachael I Morris, MbChB; Phone Number: 02071889811; Email: rachael.morris@kcl.ac.uk
    • Contact: Stephen Black, MD; Phone Number: 07810445772; Email: stephen.black@kcl.ac.uk
    • Sub-Investigator: Rachael I Morris, MBChB
    • Principal Investigator: Stephen A Black, MD
    • Sub-Investigator: Richard Bruce, PhD
    • Sub-Investigator: Aimee Brame, PhD
    • Sub-Investigator: Philip Marino, PhD
    • Sub-Investigator: Alberto Smith, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Group 4:

All of the above, plus:

• Previous DVT or PE
• Known, or clinical signs of chronic venous disease as judged by the chief investigator e.g. varicose veins, leg ulcers.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Venous outflow obstruction extending to inferior vena cava, symptomatic with dyspnoea; Baseline assessments Post-operative assessments if applicable	Diagnostic test: Cardiopulmonary exercise test (CPET); Cardiopulmonary exercise testing using cycle ergonomenter; Diagnostic test: Exercise cardiac MRI; Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET; Other: 6 minute walk test; 6MWT; Diagnostic test: Blood tests; FBC, U&E, LFTS; Other: Quality of life questionnaires; SF36, EQ5D, VEINES-QoL/Sym; Other: Repeat baseline assessments; repeat baseline; Diagnostic test: MR venogram; MRI scan of venous system
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); Cardiopulmonary exercise testing using cycle ergonomenter; Diagnostic test: Exercise cardiac MRI; Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET; Other: 6 minute walk test; 6MWT; Diagnostic test: Blood tests; FBC, U&E, LFTS; Other: Quality of life questionnaires; SF36, EQ5D, VEINES-QoL/Sym; Other: Repeat baseline assessments; repeat baseline; Diagnostic test: MR venogram; MRI scan of venous system
Unilateral iliac venous outflow obstruction; Baseline assessments Post-operative assessments if applicable	Diagnostic test: Cardiopulmonary exercise test (CPET); Cardiopulmonary exercise testing using cycle ergonomenter; Diagnostic test: Exercise cardiac MRI; Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET; Other: 6 minute walk test; 6MWT; Diagnostic test: Blood tests; FBC, U&E, LFTS; Other: Quality of life questionnaires; SF36, EQ5D, VEINES-QoL/Sym; Other: Repeat baseline assessments; repeat baseline; Diagnostic test: MR venogram; MRI scan of venous system
Age and sex matched controls; Baseline assessments	Diagnostic test: Cardiopulmonary exercise test (CPET); Cardiopulmonary exercise testing using cycle ergonomenter; Diagnostic test: Exercise cardiac MRI; Exercise cardiac MRI using supine cycle, participants exercised to peak workload as determined by CPET; Other: 6 minute walk test; 6MWT; Other: Quality of life questionnaires; SF36, EQ5D, VEINES-QoL/Sym; Other: Repeat baseline assessments; repeat baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Anticipated): October 20, 2022
• Study Completion (Anticipated): April 20, 2023

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: 254956

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No