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Rapid Assessment of Potential Ischaemic Heart Disease With CTCA (RAPID-CTCA)

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ClinicalTrials.gov Identifier: NCT02284191
Recruitment Status : Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
This study aims to investigate the effect of early CTCA in patients with suspected or confirmed Acute Coronary Syndrome (ACS) presenting to the Emergency Department (ED) or Medical Assessment Unit (MAU), upon interventions, event rates and health care costs in a pragmatic clinical trial and economic evaluation up to 1 year after the trial intervention. The primary objective will be to investigate the effect of the intervention on all-cause death or subsequent type 1 or type 4b MI at one year, measured as time to first such event.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Radiation: CT Coronary Angiogram Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1749 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Role of Early CT Coronary Angiography in the Evaluation, Intervention and Outcome of Patients Presenting to the Emergency Department With Suspected or Confirmed Acute Coronary Syndrome.
Actual Study Start Date : March 2015
Actual Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: CT Coronary Angiogram
CT Coronary Angiogram plus standard care
Radiation: CT Coronary Angiogram
Completion of a CT Coronary Angiogram

No Intervention: Standard Care
Standard care only



Primary Outcome Measures :
  1. The primary end-point will be all-cause death or subsequent non-fatal type 1 or type 4b MI at one year, measured as time to first such event. [ Time Frame: 1 year ]
    Myocardial infarction will be defined according to the most recent Universal Definition [Thygesen K, 2012] and will be adjudicated by two independent cardiologists blinded to the intervention.


Secondary Outcome Measures :
  1. Coronary Heart Disease (CHD) death or subsequent non-fatal MI [ Time Frame: 1 year ]
    Death or MI

  2. Cardiovascular Disease (CVD) death or subsequent non-fatal MI [ Time Frame: 1 year ]
    CVD Death

  3. Subsequent Non-fatal MI [ Time Frame: 1 year ]
    MI

  4. Coronary Heart Disease death [ Time Frame: 1 year ]
    CHD Death

  5. Cardiovascular death [ Time Frame: 1 year ]
    CVS Death

  6. All-cause death [ Time Frame: 1 year ]
    Death

  7. Coronary Heart Disease (CHD) death or subsequent non-fatal MI (type 1 or 4b) [ Time Frame: 1 year ]
    CHD and MI

  8. Subsequent Non-fatal MI (type 1 or 4b) [ Time Frame: 1 year ]
    Non Fatal MI

  9. Non-cardiovascular death [ Time Frame: 1 year ]
    Non CVS Death

  10. Invasive coronary angiography [ Time Frame: 1 year ]
    Angiography procedures

  11. Coronary revascularisation [ Time Frame: 1 year ]
    Revascularisation procedures

  12. Percutaneous coronary intervention [ Time Frame: 1 year ]
    PCI interventions

  13. Coronary artery bypass graft [ Time Frame: 1 year ]
    CABG procedures

  14. Proportion of patients prescribed ACS therapies during index hospitalisation [ Time Frame: 1 year ]
    ACS therapies

  15. Proportion of patients discharged on preventative treatment or have alteration in dosage of preventative treatment during index hospitalisation [ Time Frame: 1 year ]
    Preventative treatments

  16. Length of Stay for Index Hospitalisation [ Time Frame: 1 year ]
    Length of Stay

  17. Representation or rehospitalisation with suspected ACS/recurrent chest pain within 12 months after index hospitalisation [ Time Frame: 1 year ]
    Hospital attendances for ACS

  18. Chest pain symptoms up to 12 months [ Time Frame: 1 year ]
    Patient symptoms measured by ROSE questionnaire

  19. Quality of Life (measured by EQ-5D-5L up to 12 months) [ Time Frame: 1 year ]
    Quality of life measured by EQ-5D-5L questionnaire

  20. Patient satisfaction at 1 month [ Time Frame: 1 year ]
    Participant questionnaire (11 questions) asking their viewpoint on the care they received during their baseline admission.

  21. Clinician certainty of presenting diagnosis after CTCA [ Time Frame: 1 year ]
    Clinician certainty

  22. Proportion of patients with alternative cardiovascular diagnoses identified on CTCA [ Time Frame: 1 year ]
    Safety assessment AE and SAEs

  23. Proportion of patients with non-cardiovascular diagnosis identified on CTCA [ Time Frame: 1 year ]
    Safety Assessment AEs and SAEs

  24. Radiation exposure from CTCA as trial intervention [ Time Frame: 1 year ]
    Safety Assessment AEs and SAEs

  25. Cost effectiveness [ Time Frame: 1 year ]
    Estimated in terms of the lifetime incremental cost per quality-adjusted life year (QALY) gained.



Information from the National Library of Medicine

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

INCLUSION CRITERIA

Patient ≥18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of:

  • ECG abnormalities e.g. ST segment depression >0.5 mm;
  • History of ischaemic heart disease (where the clinician assessing patient confirms history based on patient history or available records);
  • Troponin elevation above the 99th centile of the normal reference range or increase in high sensitivity troponin meeting European Society of Cardiology criteria for 'rule-in' or myocardial infarction (NB troponin assays will vary from site to site; local laboratory reference standards will be used).

EXCLUSION CRITERIA

  • Signs, symptoms, or investigations supporting high-risk ACS:

    • ST elevation MI;
    • ACS with signs or symptoms of acute heart failure or circulatory shock;
    • Crescendo episodes of typical anginal pain;
    • Marked or dynamic ECG changes e.g. ST depression of >3 mm
    • Clinical team have scheduled early invasive coronary angiography on day of trial eligibility assessment.
  • Patient inability to undergo CT:

    • Severe renal failure (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min);
    • Contrast allergy;
    • Beta blocker intolerance (if no alternative heart rate limiting agent available/suitable) or allergy ;
    • Inability to breath hold;
    • Atrial fibrillation (where mean heart rate is anticipated to be greater than 75 beats per minute after beta blockade).
  • Patient has had invasive coronary angiography or CTCA within last 2 years and the previous investigation revealed obstructive coronary artery disease, or patient had either investigation within the last 5 years and the result was normal.
  • Previous recruitment to the trial;
  • Known pregnancy or currently breast feeding;
  • Inability to consent;
  • Further investigation for ACS would not in the patient's interest, due to limited life expectancy, quality of life or functional status;
  • Prisoners

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): NCT02284191


Locations
Show Show 37 study locations
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
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Principal Investigator: Alasdair J Gray NHS Lothian
  Study Documents (Full-Text)

Documents provided by University of Edinburgh:
Statistical Analysis Plan  [PDF] August 19, 2020

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02284191    
Other Study ID Numbers: RAPID-CTCA-2014
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Keywords provided by University of Edinburgh:
Radiology
Acute Medicine
Emergency Medicine
Cardiology
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases