Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Very Early Versus Delayed Angiography +/- Intervention on Outcomes in Patients With NSTEMI (RapidNSTEMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707314
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
British Heart Foundation
University of East Anglia
University of Leicester
Information provided by (Responsible Party):
University Hospitals, Leicester

Brief Summary:
Prospective, open, multicentre, randomised controlled trial in patients with higher risk non-ST elevation myocardial infarction acute coronary syndrome

Condition or disease Intervention/treatment Phase
Cardiovascular; Attack Procedure: Angiography with follow-on revascularisation if indicated Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-centre parallel design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Very Early Angiography +/- Intervention Versus Standard of Care on Outcomes in Patients With Non ST-elevation Myocardial Infarction
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Group A: Immediate angiography
Immediate angiography with follow-on revascularisation if indicated
Procedure: Angiography with follow-on revascularisation if indicated
Angiography with follow-on revascularisation (if indicated)

Group B: Standard of care angiography
Standard of care angiography with follow-on revascularisation if indicated (within 3-4 days, but will vary depending on recruiting centre)
Procedure: Angiography with follow-on revascularisation if indicated
Angiography with follow-on revascularisation (if indicated)




Primary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: 12 months ]
    Incidence of the composite of all-cause mortality, new myocardial infarction and admission for heart failure within 12 months following randomisation


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 12 months ]
    Incidence of all-cause mortality

  2. New myocardial infarction [ Time Frame: 12 months ]
    Incidence of new myocardial infarction

  3. Heart failure [ Time Frame: 12 months ]
    Incidence of admission for heart failure

  4. Cardiovascular mortality [ Time Frame: 12 months ]
    Incidence of cardiovascular mortality

  5. Length of in-patient stay [ Time Frame: Through study completion, 3 years ]
    Length of in-patient stay (defined as randomisation to first discharge) in days

  6. All-cause mortality prior to planned coronary angiography [ Time Frame: During index admission ]
    Incidence of all-cause mortality prior to planned coronary angiography following index admission with NSTEMI

  7. New myocardial infarction prior to planned coronary angiography [ Time Frame: During index admission ]
    Incidence of new myocardial infarction prior to planned coronary angiography following index admission with NSTEMI

  8. Major bleeding prior to planned coronary angiography [ Time Frame: During index admission ]
    Incidence of major bleeding (classified as BARC 3-5) prior to planned coronary angiography following index admission with NSTEMI

  9. Admission for ischaemia-driven revascularisation [ Time Frame: 12 months ]
    Incidence of admission for ischaemia-driven revascularisation

  10. Admission for any cause [ Time Frame: 12 months ]
    Incidence of admission for any cause

  11. Quality of life measured using Seattle Angina Questionnaire [ Time Frame: 12 months ]
    Quality of life measured using Seattle Angina Questionnaire at 24 hours post procedure, 1 month, 6 months and 12 months

  12. Quality of life measured using EuroQoL-5D-5L questionnaire [ Time Frame: 12 months ]
    Quality of life measured using the EuroQoL-5D-5L questionnaire at 24 hours post procedure, 1 month, 6 months and 12 months

  13. BARC 3-5 bleeding [ Time Frame: 12 months ]
    Incidence of Bleeding Academic Research Consortium (BARC) 3-5 classified bleeding as in-patient, and up to 12 months

  14. Stroke [ Time Frame: 12 months ]
    Incidence of stroke

  15. Cost effectiveness [ Time Frame: 12 months ]
    Cost effectiveness of immediate PCI versus standard care

  16. Left ventricular ejection fraction on cardiac MRI [ Time Frame: 7 days (+/-3 days) ]
    Left ventricular ejection fraction on cardiac MRI

  17. Infarct size on cardiac MRI [ Time Frame: 7 days (+/-3 days) ]
    Infarct size on cardiac MRI

  18. Proportion of patients needing emergency/urgent revascularisation [ Time Frame: 3-4 days (standard of care timing angiography will vary between recruiting centres) ]
    Proportion of patients needing emergency/urgent revascularisation (in group B)

  19. Total access site complications [ Time Frame: 12 months ]
    Incidence of total VARC-2 classified access site complications as in-patient, and up to 12 months

  20. Major access site complications [ Time Frame: 12 months ]
    Incidence of major VARC-2 classified access site complications as in-patient, and up to 12 months

  21. Sensitivity and specificity of novel biomarkers for predicting need for revascularisation [ Time Frame: 3-4 days (standard of care timing angiography will vary between recruiting centres) ]
    Sensitivity and specificity of novel biomarkers in predicting which patients do or do not require PCI following diagnostic angiography



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 18 years of age and over
  • Patients presenting to hospitals with a clinical diagnosis of non-ST elevation myocardial infarction comprising:

    • Ischaemic symptoms (as defined in Appendix III of protocol)
    • Elevated high sensitivity Troponin T or I (above the normal range for individual hospitals)
  • GRACE-2.0 score (www.gracescore.org) of either:

    • ≥118 (corresponding to 6-month death >6%) OR
    • ≥90 but <118 (corresponding to 6-month death >3% but <6%)
  • If GRACE 2.0 score ≥90 or <118 must have at least one additional high risk feature:

    • Anterior location of ECG changes (leads V2 - V5)
    • ST-segment depression in 2 contiguous leads (any territory) of 0.15mV/ 1.5mm.
    • Diabetes Mellitus on medication
    • High-sensitivity Troponin I or T 3 x ULN
  • Onset of ischaemic symptoms at any time prior to admission but most recent episode within 12 hours to admission
  • Intention to perform angiography and, if indicated, follow-on revascularisation
  • Provision of assent or written consent
  • Randomisation must be performed within 6 hours of admission

Exclusion Criteria

  • ST elevation myocardial infarction
  • Evident type 2 myocardial infarction (e.g. anaemia)
  • Evidence of previous known cardiomyopathy
  • Cardiogenic Shock
  • Known severe valvular heart disease
  • Need for urgent PCI according to ESC Guidelines (haemodynamic instability, VT, VF, recurrent or persistent pain)
  • Any contraindication to PCI
  • Current participation in another intervention trial

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): NCT03707314


Contacts
Layout table for location contacts
Contact: Nafisa Boota 0116 229 7298 ext 7298 rapidnstemi@leicester.ac.uk
Contact: Rachel W Hobson 0116 229 7175 ext 7175 rwh8@leicester.ac.uk

Locations
Layout table for location information
United Kingdom
Glenfield Hospital, University Hospitals of Leicester NHS Trust Recruiting
Leicester, United Kingdom
Contact: Andrew Ladwiniec, MA MD MRCP         
Sponsors and Collaborators
University Hospitals, Leicester
British Heart Foundation
University of East Anglia
University of Leicester
Investigators
Layout table for investigator information
Study Chair: Tony Gershlick University Hospitals, Leicester
Layout table for additonal information
Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT03707314    
Other Study ID Numbers: EDGE 89678
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospitals, Leicester:
NSTEMI