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Improved Prediction of Functional Recovery After Revascularisation Using Combined Assessment of Myocardial Ischaemia and Viability by CMR - Pilot Study

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ClinicalTrials.gov Identifier: NCT03798652
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
King's College London

Brief 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 revascularisation.

Condition or disease Intervention/treatment
Cardiovascular Diseases Ischemic Cardiomyopathy Cardiac Ischemia Device: Research CMR scan Device: Research 3D transthoracic echocardiogram Other: 6-minute walk test

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.

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Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Improved Prediction of Functional Recovery After Revascularisation Using Combined Assessment of Myocardial Ischaemia and Viability by CMR - Pilot Study
Actual Study Start Date : March 3, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Device: Research CMR scan
CMR scanning at a 3Tesla scanner at King's College London

Device: Research 3D transthoracic echocardiogram
The scan is required to assess left ventricular systolic function

Other: 6-minute walk test
Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Recovery of overall Left Ventricular ejection fraction [ Time Frame: 12 months ]
  2. Change in Left Ventricular end diastolic volume [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Composite of all cause death hospitalisation for heart failure [ Time Frame: 12 months ]
  2. 6- minute walk test [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  1. Known coronary artery disease referred for isolated surgical revascularisation;
  2. Wall motion abnormalities at rest in at least two adjacents segments on standard AHA model supplied by a diseased coronary artery;
  3. LV EF <45%.

Exclusion Criteria:

  1. Contraindications to CMR, adenosine and low-dose dobutamine;
  2. GFR <30 ml/min
  3. 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;
  4. Sustained Ventricular Tachycardia/Ventricular Fibrillation<72 hours prior to enrolment;
  5. Implantable Cardioverter Defibrilator;
  6. Pregnancy;
  7. Age<18 years
  8. Previous established diagnosis of non ischaemic cardiomyopathy;
  9. Severe concomitant valvular disease;
  10. Recente acute coronary syndrome(<4 weeks prior to enrolment).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798652


Contacts
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Contact: Amedeo Chiribiri, Dr +44 (0)2071887188 Amedeo.Chiribiri@kcl.ac.uk
Contact: Russell Franks, Dr Russell.Franks@kcl.ac.uk

Locations
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United Kingdom
King's College London Recruiting
London, United Kingdom, SE1 7EH
Contact: Amedeo Chiribiri, Dr    +44 (0)2071887188    Amedeo.Chiribiri@kcl.ac.uk   
Contact: Russell Franks, Dr    +44 (0)2071887188    russell.franks@kcl.ac.uk   
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Amedeo Chiribiri, Dr King's College London
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03798652    
Other Study ID Numbers: 247309
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
Perfusion
Viability
Additional relevant MeSH terms:
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Cardiovascular Diseases
Cardiomyopathies
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Heart Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases