Trial of Cardiac CT in Acute Chest Patients With Intermediate Level Initial High-sensitivity Cardiac Troponin

NCT03583320 | Unknown DMC

• 1 other identifier: IRAS ID: 223704
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who present to the emergency department (ED) with acute chest pain (ACP) possibly due to Coronary artery disease (CAD), with a normal heart tracing (ECG), need to have further troponin blood tests to confirm or exclude a heart attack. After initial troponin testing, a significant 50-85% of patients are said to be in an "observational zone" as one cannot confirm or exclude a diagnosis of a heart attack. Even after repeat blood testing, 22-33% remain in this "observational zone". These patients can be challenging to manage as they are not safe to be discharged home, but they also cannot be treated as a heart attack. This contributes to ED overcrowding and uncertainty in treatment plans.

Conditions

Chest Pain; Coronary Artery Disease; Acute Coronary Syndrome; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• The primary objective will be to compare median hospital length of stay in each arm.

  as above

  Through 1 year

Secondary Outcomes (12)

• Number of admissions in each arm; • Number of admissions in each arm; Number of hospital admissions in each arm

  Through 1 year

• Number of hospital discharges in each arm

  Through 1 year

• Time taken to arrive at decision for admission or discharge

  Through 1 year

• Number of additional investigations during hospital stay (if admitted)

  Through 1 year

• Proportion of patients with completeness of diagnosis on discharge

  Through 1 year

Other Outcomes (4)

• Differences in terms of radiation dose in each arm.

  Through 1 year

• Cost of the index emergency department hospital visit

  Through 1 year

• Total hospital admission costs in each arm

  Through 1 year

Study Arms (2)

Arm A (Cardiac CT)

EXPERIMENTAL

Patients randomised to Arm A i.e. the intervention arm will under go standard of care patient hospital management but will also have cardiac CT angiogram (CTCA) carried out. Their subsequent clinical management will be left to clinician discretion in light of the additional CTCA results.

Diagnostic Test: Cardiac CT angiogram

Arm B (Standard of care arm)

NO INTERVENTION

Patients randomised to Arm B will receive usual standard of care management guided by serial troponin blood tests. These patients will also under go cardiac CT angiogram (CTCA) but these scans will not be used for the patients' in-hospital care. Furthermore, unlike Arm A, CTCA interpretation followed by reporting will not take place in the acute hospital setting and therefore will be carried out within the following three weeks. Should the CTCA be found to have significant high risk CAD e.g. \>50% stenosis in the left main (LM) coronary artery, and/or \>50% stenosis in the proximal left anterior descending (LAD) coronary artery, they will be un-blinded and kept in a separate registry. Their results will be discussed with the hospital care team and if they have not had any invasive coronary imaging during the preceding hospital admission, an urgent cardiology out-patient referral will be made to enable further clinical management.

Interventions

Cardiac CT angiogram DIAGNOSTIC_TEST

To the best of the author's knowledge this study will provide the first prospective and randomised data pertaining to hospital length of stay as a primary outcome in the use of CTCA on this acute chest pain cohort (with an intermediate observational zone category) on initial high sensitivity-cardiac troponin (hs-cTn) results presenting to the emergency department in a tertiary care hospital.

Arm A (Cardiac CT)

Eligibility Criteria

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

You may qualify if:

• Patients above 18 years of age with ischaemic sounding chest pain prompting visit to the emergency department (suspected ACS).
• No-ischaemic ECG changes (i.e. no ST-segment elevation or depression 1mm in 2 or more contiguous leads, and/or T-wave inversions).
• Episode of chest pain within last 12 hours.
• Initial troponin in the intermediate range (5-50ng/L).

You may not qualify if:

• STEMI.
• Signs and symptoms of acute heart failure and/or haemodynamic instability.
• Dynamic ischaemic ECG changes.
• Patient not suitable to undergo CTCA
• Inability to breath hold for 10 seconds
• Severe renal impairment (eGFR \<30 mL/min)
• Contraindication to beta-blockers (not relevant for patients with baseline sinus rhythm at rate of \<63bpm)
• Atrial Fibrillation on ECG.
• Patients with known significant obstructive coronary artery disease (\>50% stenosis) on previous invasive or CT coronary angiogram.
• Patients with previous PCI/CABG revascularisation.
• Patients with a history of congenital heart disease.
• Patients with known coronary artery anomalies.
• Patients who lack capacity to give consent or participate in the study.
• Previous recruitment to the present study.
• Known pregnancy or patients who are currently breast feeding.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St. Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (26)

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MeSH Terms

Conditions

Chest Pain; Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: As stated earlier for patients assigned to Arm B i.e. the control arm (standard of care arm) who undergo CTCA, the results will not be released to the patient and their medical care givers in hospital. CTCA interpretation followed by reporting will not take place in the acute hospital setting and therefore will be carried out within the following three weeks. Should the CTCA be found to have significant high risk CAD e.g. \>50% stenosis in the left main (LM) coronary artery, and/or \>50% stenosis in the proximal left anterior descending (LAD) coronary artery, they will be un-blinded and kept in a separate registry. Their results will be discussed with the hospital care team and if they have not had any invasive coronary imaging during the preceding hospital admission, an urgent cardiology out-patient referral will be made to enable further clinical management.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Once patients consent to participate in the study, they will be randomised into the intervention group (i.e. with CTCA) or the control group (i.e. hs-cTn based standard of care) on a 1:1 ratio. For purposes of Study 2, the control group of patients will also be consented to undergo CTCA. However, CTCA will not form part of their in-patient clinical management as the clinical teams will be blinded from CTCA findings (except for cases of prognostically significant coronary disease e.g. 50% stenosis of the LM and/or proximal LAD coronary arteries).

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: July 11, 2018
• Study Start: January 12, 2018
• Primary Completion: April 5, 2019
• Study Completion: April 30, 2020
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: The IPD that underlie results in a publication will become available in publications during 24 months following recruitment of the final patient in the trial.
• Access Criteria: IPD may be looked at by the primary research team, research regulatory authorities, responsible individuals from King's College London and Guy's and St. Thomas' Hospital.

Locations

GB (1)