Myocardial Perfusion ImagingExSPECTNCT03864497
Myocardial Perfusion Imaging in Liver Transplantation Candidates
An observational study of Myocardial Perfusion Imaging and Liver Failure, run by University Hospital Birmingham NHS Foundation Trust.
Trial summary
The optimal screening strategy for assessment of coronary artery disease in patients with end-stage liver disease (ESLD) is unclear. Although consensus based guidelines support noninvasive stress testing prior to orthotopic liver transplantation (OLT), no prospective studies are available to inform the clinician on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Perfusion Imaging, Liver Failure
- What is being tested?
- Myocardial perfusion imaging
- Type of treatment
- Surgery or procedure
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with end-stage liver disease were identified after referral to the Queen Elizabeth Hospital Birmingham for CV risk stratification as part of a pre-transplant screening work-up. Subjects were referred for non-invasive CV risk assessment based on the above criteria.
Who may be able to join
- Liver transplantation candidates with one or more of the following:
- inability to perform >4 METs by history
- insulin-treated diabetes mellitus
- serum creatinine >152μmol/l
- history of MI, PCI or CABG
- stable angina
- cerebrovascular disease
- peripheral vascular disease
Who cannot join
- Age < 18 years
- Pregnancy
- Contraindication to liver transplantation
About this study
Official title: Exercise Capacity and Single Photon Emission Computed Tomography in Liver Transplantation Candidates Study
The optimal screening strategy for assessment of coronary artery disease in patients with end-stage liver disease (ESLD) is unclear. Although consensus based guidelines support noninvasive stress testing prior to orthotopic liver transplantation (OLT), no prospective studies are available to inform the clinician on perioperative risk stratification. This observational cohort study was designed to determine the prognostic utility of single photon emission computed tomography (SPECT) imaging in OLT candidates.
Read the detailed description
Controversy over whether SPECT imaging offers clinical utility in ESLD has been fuelled by conflicting reports on its accuracy to diagnose CAD in this setting. Moreover, there are no studies examining whether SPECT imaging provides any incremental prognostic value beyond functional testing in this high-risk cohort. We sought to determine the relative importance of CV risk factors, functional capacity and SPECT perfusion results as independent predictors of cardiovascular mortality in OLT candidates.
- Conditions
- Myocardial Perfusion Imaging, Liver Failure
- Being tested
- Myocardial perfusion imaging
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial perfusion imagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Orthotopic liver transplantation candidates | No intervention, imaging test and risk stratification as part of routine clinical care. Receives: Procedure: Myocardial perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Measured: 10 years
Secondary outcomes (2)
Major adverse cardiovascular event
Measured: 10 years
All-cause mortality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study startSep 2007
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Perfusion ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William E Moody, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Richard P Steeds, MD, Study director, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864497
- Sponsor's protocol ID
- CARMS-14536
- Acronym
- ExSPECT
- Status last verified
- Jun 2019
- First submitted
- 4 Mar 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moody WE, Holloway B, Arumugam P, Gill S, Wahid YS, Boivin CM, Thomson LE, Berman DS, Armstrong MJ, Ferguson J, Steeds RP. Prognostic value of coronary risk factors, exercise capacity and single photon emission computed tomography in liver transplantation candidates: A 5-year follow-up study. J Nucl Cardiol. 2021 Dec;28(6):2876-2891. doi: 10.1007/s12350-020-02126-z. Epub 2020 May 11.
PubMed 32394403
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capacity and Single Photon Emission Computed Tomography in Liver Transplantation Candidates Study
- ClinicalTrials.gov ID
- NCT03864497
- Acronym / sponsor ID
- ExSPECT / CARMS-14536
- Conditions
- Myocardial Perfusion Imaging, Liver Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The optimal screening strategy for assessment of coronary artery disease in patients with end-stage liver disease (ESLD) is unclear. Although consensus based guidelines support noninvasive stress testing prior to orthotopic liver transplantation (OLT), no prospective studies are available to inform the clinician on perioperative risk stratification. This observational cohort study was designed to determine the prognostic utility of single photon emission computed tomography (SPECT) imaging in OLT candidates.
Detailed description
Controversy over whether SPECT imaging offers clinical utility in ESLD has been fuelled by conflicting reports on its accuracy to diagnose CAD in this setting. Moreover, there are no studies examining whether SPECT imaging provides any incremental prognostic value beyond functional testing in this high-risk cohort. We sought to determine the relative importance of CV risk factors, functional capacity and SPECT perfusion results as independent predictors of cardiovascular mortality in OLT candidates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthotopic liver transplantation candidates | – | Procedure: Myocardial perfusion imagingNo intervention, imaging test and risk stratification as part of routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with end-stage liver disease were identified after referral to the Queen Elizabeth Hospital Birmingham for CV risk stratification as part of a pre-transplant screening work-up. Subjects were referred for non-invasive CV risk assessment based on the above criteria.
Key inclusion criteria (8 listed)
- Liver transplantation candidates with one or more of the following:
- inability to perform >4 METs by history
- insulin-treated diabetes mellitus
- serum creatinine >152μmol/l
- history of MI, PCI or CABG
Key exclusion criteria (3 listed)
- Age < 18 years
- Pregnancy
- Contraindication to liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myocardial perfusion imaging | Procedure or surgery | Orthotopic liver transplantation candidates |
Primary outcome
Cardiovascular mortality
Time frame: 10 years
2 secondary outcomes
Major adverse cardiovascular event
Time frame: 10 years
All-cause mortality
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Derived from this study: PubMed 32394403Moody WE, Holloway B, Arumugam P, Gill S, Wahid YS, Boivin CM, Thomson LE, Berman DS, Armstrong MJ, Ferguson J, Steeds RP. Prognostic value of coronary risk factors, exercise capacity and single photon emission computed tomography in liver transplantation candidates: A 5-year follow-up study. J Nucl Cardiol. 2021 Dec;28(6):2876-2891. doi: 10.1007/s12350-020-02126-z. Epub 2020 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard P Steeds, MD study director
University Hospital Birmingham NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Perfusion Imaging and Liver Failure, run by University Hospital Birmingham NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.