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Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography (TARGET-CTCA)

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ClinicalTrials.gov Identifier: NCT03952351
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
British Heart Foundation
University of Sheffield
NHS Lothian
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
University of Edinburgh

Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE September 18, 2019
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Composite of myocardial infarction or cardiac death [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
The first event of myocardial infarction or cardiac death
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03952351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Myocardial Infarction [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
    The first event of myocardial infarction (MI). MI will be defined according to the 4th Universal Definition of Myocardial Infarction
  • Cardiac death [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
    Cardiac death will be defined as death resulting from an acute myocardial infarction, sudden cardiac death, or death due to heart failure.
  • Cardiovascular death [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
    Cardiovascular death will be defined as death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular haemorrhage, and death due to other cardiovascular causes
  • Non-cardiovascular death [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
  • All-cause death [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
  • Unscheduled urgent coronary revascularisation [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
    Unscheduled urgent coronary revascularisation will be identified via record linkage from central NHS registers (e.g. the Scottish Morbidity Register by the Information Services Division (ISD) Scotland) or from extracts obtained from the participating hospitals electronic patient record system.
  • Hospital reattendance with suspected ACS [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
    Reattendance with suspected ACS will be defined as any unscheduled hospital attendance where cardiac troponin testing is performed for suspected ACS following randomisation
  • Proportion of patients with major bleeding (BARC 3-5) [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
    Bleeding will be defined according to the Bleeding Academic Research Consortium (BARC) definition of bleeding. We will use pre-defined codes from International Classification of Diseases (ICD-10) and Office of Population Censuses and Surveys (OPCS) to classify each bleeding event as per the BARC definition.
  • Symptomatic status as assessed by the short form Seattle Angina Questionnaire (SAQ-7) [ Time Frame: 3, 12 and 24 months ]
  • Quality of life as assessed by the EQ-5D-5L [ Time Frame: 3, 12 and 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2019)
  • Proportion of patients with allergy/anaphylaxis/acute kidney injury following study CTCA scan [ Time Frame: 2 weeks ]
  • Proportion of patients undergoing non-study CTCA or invasive coronary angiography (ICA) [ Time Frame: 90 days ]
  • Proportion of patients with clinically significant abnormal non-cardiac findings on study CTCA scan [ Time Frame: 2 weeks ]
  • Dose length product from study CTCA scan [ Time Frame: 2 weeks ]
  • Proportion of patients undergoing non-invasive stress test (cost-effectiveness) [ Time Frame: 90 days ]
  • Proportion of patients prescribed therapies for coronary artery disease (cost-effectiveness) [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
  • Proportion of patients undergoing planned revascularisation (cost-effectiveness) [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
  • Incremental cost per quality-adjusted life year (QALY) gained (cost-effectiveness) [ Time Frame: Randomisation through to study completion, median duration of 36 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Official Title  ICMJE Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Brief Summary

Most patients presenting to hospital with symptoms of a heart attack are sent home without further tests once a heart attack has been ruled out. Current strategies to assess patients with a suspected heart attack involve blood tests to measure troponin, a protein released into the bloodstream when the heart muscle is damaged.

Despite having had a heart attack ruled-out, some patients have unrecognised heart disease and are at risk of having a heart attack in the future. However, clinicians do not know what is the best approach to identify and treat these patients.

This study will use a heart scan known as computed tomography coronary angiogram (CTCA) to look for unrecognised heart disease in patients who have had a heart attack ruled out. In an earlier study, the Investigators performed this scan in patients referred to the outpatient cardiology clinic with stable chest pain and found that this improved the diagnosis of heart disease, leading to improvement in patient care that prevented future heart attacks.

Previous research from the Investigators has also found that troponin levels below those used to diagnose a heart attack may help to identify those who are at greater risk of having a heart attack in the future.

The aim of this study is to find out if patients with these low levels of troponin, where a heart attack has been ruled out, will benefit from CTCA to look for unrecognised coronary heart disease.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Radiation: CT Coronary Angiography (CTCA)
CTCA scan in accordance with British Society of Cardiovascular Imaging CT guidelines
Study Arms  ICMJE
  • Experimental: CTCA with standard care
    Patients will be referred for CT Coronary Angiography, ideally within 2 weeks of randomisation
    Intervention: Radiation: CT Coronary Angiography (CTCA)
  • No Intervention: Standard care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
2270
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presenting to hospital with symptoms of suspected acute coronary syndrome
  • Age 18 years and over
  • Maximum high-sensitivity cardiac troponin concentration between 5ng/L and the 99th percentile

Exclusion Criteria:

  • Diagnosis of myocardial infarction during index presentation
  • Clear alternative diagnosis or participant requires further inpatient clinical assessment
  • Recent CTCA or invasive coronary angiogram (within 1 year)
  • Patient inability to undergo CT scanning, e.g. due to severe renal failure (estimated glomerular filtration rate <30 mL/min) or major allergy to iodinated contrast media
  • Current pregnancy or breast feeding
  • Inability to give informed consent
  • Further investigation for coronary artery disease would not be in the patient's interest, e.g. due to limited life expectancy, quality of life or functional status
  • Previous randomisation into the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: TARGET-CTCA Trial Manager Target.CTCA@ed.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952351
Other Study ID Numbers  ICMJE AC18106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Following publication of the primary paper, a deidentified individual participant data set will be will be made available for data sharing purposes, subject to necessary governance approvals. Access to the deidentified dataset will be under a controlled access model.
Responsible Party University of Edinburgh
Study Sponsor  ICMJE University of Edinburgh
Collaborators  ICMJE
  • British Heart Foundation
  • University of Sheffield
  • NHS Lothian
  • NHS Greater Glasgow and Clyde
Investigators  ICMJE Not Provided
PRS Account University of Edinburgh
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP