EXERT: Exercise Physiology After Thrombosis

March 16, 2022 updated by: Guy's and St Thomas' NHS Foundation Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Guys and St Thomas' NHS Foundation Trust
        • Contact:
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
VO2 max after stenting
Time Frame: 6-8 weeks post surgery
As determined by cardiopulmonary exercise testing
6-8 weeks post surgery
Peak cardiac output during exercise
Time Frame: 6-8 weeks post surgery
as determined by exercise cardiac MRI
6-8 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guy's and St Thomas' NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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