NCT03798652

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 3, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 19, 2019

Status Verified

November 1, 2018

Enrollment Period

2.8 years

First QC Date

January 7, 2019

Last Update Submit

August 16, 2019

Conditions

Cardiovascular DiseasesIschemic CardiomyopathyCardiac Ischemia

Keywords

PerfusionViability

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (2)

  • Recovery of overall Left Ventricular ejection fraction

    12 months

  • Change in Left Ventricular end diastolic volume

    12 months

Other Outcomes (2)

  • Composite of all cause death hospitalisation for heart failure

    12 months

  • 6- minute walk test

    12 months

Study Arms (1)

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 scanDevice: Research 3D transthoracic echocardiogramOther: 6-minute walk test

Interventions

Research CMR scanDEVICE

CMR scanning at a 3Tesla scanner at King's College London

Patients referred for CABG
Research 3D transthoracic echocardiogramDEVICE

The scan is required to assess left ventricular systolic function

Patients referred for CABG
6-minute walk testOTHER

Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

Patients referred for CABG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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%.

You may not qualify if:

  • 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;
  • Age\<18 years
  • Previous established diagnosis of non ischaemic cardiomyopathy;
  • Severe concomitant valvular disease;
  • Recente acute coronary syndrome(\<4 weeks prior to enrolment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Amedeo Chiribiri, Dr

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amedeo Chiribiri, Dr

CONTACT

+44 (0)2071887188Amedeo.Chiribiri@kcl.ac.uk

Russell Franks, Dr

CONTACT

Russell.Franks@kcl.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 10, 2019

Study Start

March 3, 2019

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

August 19, 2019

Record last verified: 2018-11

Locations

GB(1)