NCT06047392

Brief Summary

This study is to explore whether a computed tomography (CT) scan of the heart arteries might improve the care of patients that have presented with a suspected Type 2 myocardial infarction (MI). The Investigators hope to demonstrate that these patients may be the ideal group of patients to benefit from cardiac CT scan imaging by; 1. confirming whether they have any disease in their heart arteries 2. demonstrating the severity of the heart artery disease 3. revealing an alternative cause for their presentation 4. avoiding the need for an invasive heart artery angiogram.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

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

Study Start

First participant enrolled

July 24, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

August 2, 2023

Last Update Submit

September 26, 2023

Conditions

Myocardial InfarctionCoronary Artery Disease

Keywords

Computed TomographyMyocardial InfarctionCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Change in primary diagnosis

    The primary outcome is a change in the primary diagnosis defined as a difference in the final diagnosis at discharge compared to the initial diagnosis prior to study recruitment. The primary outcome will therefore take account of the diagnostic effect of CTCA and any changes that might normally occur during standard care.

    At discharge from recruiting hospital (assessed up to day 30)

Secondary Outcomes (8)

  • Rate of invasive coronary angiography

    3 months

  • Major adverse cardiovascular events

    12 months

  • Rate of coronary revascularisation

    12 months

  • Rate of hospital readmission

    12 months

  • Rate of additional cardiovascular investigations

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Usual Care

NO INTERVENTION

CT coronary angiography + usual care

ACTIVE COMPARATOR
Diagnostic Test: CT coronary angiography

Interventions

CT coronary angiographyDIAGNOSTIC_TEST

Patients will undergo a CTCA according to local, standard protocol.

CT coronary angiography + usual care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with known or suspected Type 2 MI

You may not qualify if:

  • Unable to provide written informed consent
  • Known severe coronary artery disease
  • Previous PCI
  • Previous CABG
  • Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2
  • Tachycardia (\>75bpm) refractory to heart rate control
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, United Kingdom

RECRUITING

Related Publications (1)

  • Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2024 Feb 9;13(1):55-161. doi: 10.1093/ehjacc/zuad107. No abstract available.

    PMID: 37740496BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Richard Good, MD

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Travers

CONTACT

+44141 314 4012maureen.travers@ggc.scot.nhs.uk

Study Design

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

Study Record Dates

First Submitted

August 2, 2023

First Posted

September 21, 2023

Study Start

July 24, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2025

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)