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

NCT03707314 | Terminated DMC

• 1 other identifier: EDGE 89678
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular; Attack

Keywords

NSTEMI

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  Incidence of the composite of all-cause mortality, new myocardial infarction and admission for heart failure within 12 months following randomisation

  12 months

Secondary Outcomes (21)

• All-cause mortality

  12 months

• New myocardial infarction

  12 months

• Heart failure

  12 months

• Cardiovascular mortality

  12 months

• Length of in-patient stay

  Through study completion, 3 years

Study Arms (2)

Group A: Immediate angiography

OTHER

Immediate angiography with follow-on revascularisation if indicated

Procedure: Angiography with follow-on revascularisation if indicated

Group B: Standard of care angiography

OTHER

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

Interventions

Angiography with follow-on revascularisation if indicated PROCEDURE

Angiography with follow-on revascularisation (if indicated)

Group A: Immediate angiography; Group B: Standard of care angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals, Leicester: lead
• British Heart Foundation: collaborator
• University of East Anglia: collaborator
• University of Leicester: collaborator

Study Sites (1)

Glenfield Hospital, University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

Related Publications (2)

• Kite TA, Ladwiniec A, Greenwood JP, Gale CP, Anantharam B, More R, Hetherington SL, Khan SQ, O'Kane P, Rakhit R, Chase A, Barber S, Waheed G, Berry C, Flather M, McCann GP, Curzen N, Banning AP, Gershlick AH; RAPID NSTEMI Investigators. Very early invasive strategy in higher risk non-ST-elevation acute coronary syndrome: the RAPID NSTEMI trial. Heart. 2024 Mar 12;110(7):500-507. doi: 10.1136/heartjnl-2023-323513.

  PMID: 38103913 DERIVED

• Kite TA, Banning AS, Ladwiniec A, Gale CP, Greenwood JP, Dalby M, Hobson R, Barber S, Parker E, Berry C, Flather MD, Curzen N, Banning AP, McCann GP, Gershlick AH. Very early invasive angiography versus standard of care in higher-risk non-ST elevation myocardial infarction: study protocol for the prospective multicentre randomised controlled RAPID N-STEMI trial. BMJ Open. 2022 May 3;12(5):e055878. doi: 10.1136/bmjopen-2021-055878.

  PMID: 35504645 DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Adrian Banning

  Oxford University Hospitals NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-centre parallel design

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: October 16, 2018
• Study Start: November 6, 2018
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)