Cardiovascular DiseasesNCT03798652
Improved Prediction of Functional Recovery After Revascularisation Using Combined Assessment of Myocardial Ischaemia and Viability by CMR - Pilot Study
An observational study of Cardiovascular Diseases and Ischemic Cardiomyopathy, run by King's College London at 1 site in United Kingdom.
Trial summary
The study will investigate whether a new high resolution heart Magnetic Resonance Imaging scan, combining assessment of ischemia and viability by perfusion and Late Gadolinium Enhancement -Cardiac Magnetic Resonance is superior to Late Gadolinium Enhacement imaging alone in predicting functional recovery following… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Ischemic Cardiomyopathy, Cardiac Ischemia
- What is being tested?
- Research CMR scan, Research 3D transthoracic echocardiogram and 6-minute walk test
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2019to 30 Jun 2022
- 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: The patient will all the above inclusion criteria and none of the exclusion criteria will be identified from: * Referrals for cardiac MRI scans at King's College London; * Referrals for cardiac catheterisation at St. Thomas' Hospital; * Outpatient clinic referrals to St. Thomas's Hospital cardiovascular services; * Cardiovascular multi-disciolinary team meetings
Who may be able to join
- Known coronary artery disease referred for isolated surgical revascularisation;
- Wall motion abnormalities at rest in at least two adjacents segments on standard AHA model supplied by a diseased coronary artery;
- LV EF <45%.
Who cannot join
- Contraindications to CMR, adenosine and low-dose dobutamine;
- GFR <30 ml/min
- Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or Intra-aortic Ballon Pump/left ventricular assist device therapy < 72 hours prior to enrolment;
- Sustained Ventricular Tachycardia/Ventricular Fibrillation<72 hours prior to enrolment;
- Implantable Cardioverter Defibrilator;
- Pregnancy;
Show all 10Show fewer
- Age<18 years
- Previous established diagnosis of non ischaemic cardiomyopathy;
- Severe concomitant valvular disease;
- Recente acute coronary syndrome(<4 weeks prior to enrolment).
Trial locations and contacts
1 site in 1 country.
Russell Franks, Dr contact
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE1 7EH
Amedeo Chiribiri, Dr, +44 (0)2071887188, Amedeo.Chiribiri@kcl.ac.uk
Russell Franks, Dr, +44 (0)2071887188, russell.franks@kcl.ac.uk
About this study
The study will investigate whether a new high resolution heart Magnetic Resonance Imaging scan, combining assessment of ischemia and viability by perfusion and Late Gadolinium Enhancement -Cardiac Magnetic Resonance is superior to Late Gadolinium Enhacement imaging alone in predicting functional recovery following revascularisation.
Read the detailed description
Coronary artery disease, where the heart's blood supply is restricted by narrowings or blockages, is the commonest cause of heart failure. This condition is called ischaemic cardiomyopathy. In some patients, treating these narrowings/ blockages with by-pass surgery or stents, known as "revascularisation", helps improve the pumping strength of the heart but it is currently difficult to predict which patients will benefit. The best test the investigators currently have to predict who will benefit from revascularisation is an Magnetic Resonance Imaging scan of the heart which looks for how much the heart has been scarred. Hearts with no scar usually improve after revascularisation and hearts with lots of scar usually do not. However, lots of patients fall into the middle and have moderate amounts of scar. The Magnetic Resonance Imaging scan isn't good at predicting if this group of patients will benefit from revascularisation. Revascularisation procedures, including heart by-passes, are not without risk and often require time in intensive care, several days in hospital and a long recovery period at home. If the investigators can develop a better test which is more accurate at predicting whether hearts with moderate scar will improve then they will be able to provide better care for patients by ensuring only those patients who will get benefit from revascularisation are put through the procedure.
This study will investigate whether a new high-resolution heart Magnetic Resonance Imaging scan, which looks at not only levels of scar but also the quality of blood supply, is more accurate than current MRI scans at predicting heart recovery after revascularisation in patients with moderate amounts of scar.
- Being tested
- Research CMR scan, Research 3D transthoracic echocardiogram, 6-minute walk test
- Keywords
- Perfusion, Viability
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research CMR scanDevice
CMR scanning at a 3Tesla scanner at King's College London
Research 3D transthoracic echocardiogramDevice
The scan is required to assess left ventricular systolic function
6-minute walk testOther
Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for CABG | Patients with known coronary artery disease referred for isolated surgical revascularisation, who will be invited to attend our facility for a research CMR scan, a research 3D transthoracic echocardiogram and a 6 minute walk test Receives: Device: Research CMR scan; Device: Research 3D transthoracic echocardiogram; Other: 6-minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of the regional systolic function
Recovery will be defined as a reduction in average resting wall motion score equal or more than 1. The region of interest will be defined as the segments of myocardium subentended by the revascularised coronary stenosis.
Segments will be considered to have been revascularised if surgical by-pass to the diseased coronary artery subtending the segment is considered successful by the surgical team at the time of surgery.
Measured: 12 months
Secondary outcomes (2)
Recovery of overall Left Ventricular ejection fraction
Measured: 12 months
Change in Left Ventricular end diastolic volume
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start3 Mar 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amedeo Chiribiri, Dr, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798652
- Sponsor's protocol ID
- 247309
- Status last verified
- Nov 2018
- First submitted
- 7 Jan 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Prediction of Functional Recovery After Revascularisation Using Combined Assessment of Myocardial Ischaemia and Viability by CMR - Pilot Study
- ClinicalTrials.gov ID
- NCT03798652
- Acronym / sponsor ID
- 247309
- Keywords
- Perfusion, Viability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 10 Jan 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 study will investigate whether a new high resolution heart Magnetic Resonance Imaging scan, combining assessment of ischemia and viability by perfusion and Late Gadolinium Enhancement -Cardiac Magnetic Resonance is superior to Late Gadolinium Enhacement imaging alone in predicting functional recovery following revascularisation.
Detailed description
Coronary artery disease, where the heart's blood supply is restricted by narrowings or blockages, is the commonest cause of heart failure. This condition is called ischaemic cardiomyopathy. In some patients, treating these narrowings/ blockages with by-pass surgery or stents, known as "revascularisation", helps improve the pumping strength of the heart but it is currently difficult to predict which patients will benefit. The best test the investigators currently have to predict who will benefit from revascularisation is an Magnetic Resonance Imaging scan of the heart which looks for how much the heart has been scarred. Hearts with no scar usually improve after revascularisation and hearts with lots of scar usually do not. However, lots of patients fall into the middle and have moderate amounts of scar. The Magnetic Resonance Imaging scan isn't good at predicting if this group of patients will benefit from revascularisation. Revascularisation procedures, including heart by-passes, are not without risk and often require time in intensive care, several days in hospital and a long recovery period at home. If the investigators can develop a better test which is more accurate at predicting whether hearts with moderate scar will improve then they will be able to provide better care for patients by ensuring only those patients who will get benefit from revascularisation are put through the procedure.
This study will investigate whether a new high-resolution heart Magnetic Resonance Imaging scan, which looks at not only levels of scar but also the quality of blood supply, is more accurate than current MRI scans at predicting heart recovery after revascularisation in patients with moderate amounts of scar.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for CABG | – | Device: Research CMR scan, Device: Research 3D transthoracic echocardiogram, Other: 6-minute walk testPatients with known coronary artery disease referred for isolated surgical revascularisation, who will be invited to attend our facility for a research CMR scan, a research 3D transthoracic echocardiogram and a 6 minute walk test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient will all the above inclusion criteria and none of the exclusion criteria will be identified from: * Referrals for cardiac MRI scans at King's College London; * Referrals for cardiac catheterisation at St. Thomas' Hospital; * Outpatient clinic referrals to St. Thomas's Hospital cardiovascular services; * Cardiovascular multi-disciolinary team meetings
Key inclusion criteria (3 listed)
- Known coronary artery disease referred for isolated surgical revascularisation;
- Wall motion abnormalities at rest in at least two adjacents segments on standard AHA model supplied by a diseased coronary artery;
- LV EF <45%.
Key exclusion criteria (10 listed)
- Contraindications to CMR, adenosine and low-dose dobutamine;
- GFR <30 ml/min
- Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or Intra-aortic Ballon Pump/left ventricular assist device therapy < 72 hours prior to enrolment;
- Sustained Ventricular Tachycardia/Ventricular Fibrillation<72 hours prior to enrolment;
- Implantable Cardioverter Defibrilator;
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 |
|---|---|---|
| Research CMR scanCMR scanning at a 3Tesla scanner at King's College London | Device | Patients referred for CABG |
| Research 3D transthoracic echocardiogramThe scan is required to assess left ventricular systolic function | Device | Patients referred for CABG |
| 6-minute walk testSub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. | Other | Patients referred for CABG |
Primary outcome
Recovery of the regional systolic function
Time frame: 12 months
Recovery will be defined as a reduction in average resting wall motion score equal or more than 1. The region of interest will be defined as the segments of myocardium subentended by the revascularised coronary stenosis. Segments will be considered to have been revascularised if surgical by-pass to the diseased coronary artery subtending the segment is considered successful by the surgical team at the time of surgery.
2 secondary outcomes
Recovery of overall Left Ventricular ejection fraction
Time frame: 12 months
Change in Left Ventricular end diastolic volume
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Russell Franks, Dr contact
Amedeo Chiribiri, Dr principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Ischemic Cardiomyopathy, run by King's College London at 1 site in United Kingdom.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amedeo Chiribiri, Dr (+44 (0)2071887188, Amedeo.Chiribiri@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of the regional systolic function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2019.