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NCT Number: NCT04748237

Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

The aim is to determine whether a diagnostic strategy including early coronary computed tomographic angiography in intermediate-risk patients presenting to the Emergency Department with chest pain reduces the composite endpoint of death, readmission because of myocardial infarction or unstable angina requiring revascularization.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danderyd Hospital

Stockholm, 18288, Sweden

Location status: Recruiting

Location contact

Henrik Löfmark, MD

CONTACT

[email protected]

Liselotte Persson, RN

CONTACT

[email protected]

About this study

Patients presenting to the ED with chest pain or other symptoms suggestive of ACS, without acute MI but with an intermediate risk (HEART-score >3) will after written informed consent be randomized to either a strategy with an initial CCTA or not.

Patients randomized to strategy including early CCTA will receive standard care according to responsible physician and perform a CCTA as soon as possible (in most cases within 24 hours, but at least within 21 days).The result will be presented to the responsible physician who will plan further care of the patients.

Patients randomized to a strategy not including early CCTA will receive further care (including examinations) according to responsible physician but not include early CCTA. These patients will often undergo a non-invasive functional test, such as Exercise-ECG, stress echocardiography or nuclear imaging according to local routines, but not always.

All patients should receive optimal prevention according to current guidelines. The responsible physician will be encouraged to initiate secondary prevention measures if examinations show signs of CAD.

The primary endpoint is composite of death, readmission because of MI or unstable angina requiring revascularization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥18 years.
  • Within 24 hours from presenting to the ED with chest pain or other symptoms suggestive of coronary artery disease (CAD)
  • HEART-score >3 (according to http://www.heartscore.nl/)
  • Written informed consent obtained

Exclusion criteria

  • Any condition that may influence the patient's ability to comply with study protocol.
  • Acute MI
  • Known obstructive CAD (>50%) or previous PCI or CABG.
  • Clear alternative diagnosis
  • Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
  • Major allergy to iodinated contrast media
  • Circumstances making high quality images unlikely.
  • Not a Swedish resident with a personal ID-number.
  • Pregnancy or breast feeding
  • Further investigation for CAD not indicated, due to limited life expectancy, quality of life or functional status
  • Previous inclusion in the trial

Treatment and study plan

Coronary computed tomopraphic angiography

Diagnostic Test

CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.

Primary outcomes

  1. The composite of death, readmission because of MI or unstable angina requiring revascularization

    Time frame: through study completion, an average of 5 year

    death of any cause, readmission because of MI (I21) or revascularization because of unstable angina not related to the index event

Secondary outcomes

  1. Death or readmission because MI

    Time frame: through study completion, an average of 5 year

    death of any cause, readmission because of MI (I21)

  2. Death

    Time frame: through study completion, an average of 5 year

    death of any cause

  3. Cardiovascular death

    Time frame: through study completion, an average of 5 year

    death because of cardiovascular cause (I00-99)

  4. MI (fatal or non-fatal)

    Time frame: through study completion, an average of 5 year

    readmission because of MI or death because of MI (I21)

  5. Readmission because of unstable angina requiring revascularization

    Time frame: through study completion, an average of 5 year

    revascularization because of unstable angina not related to the index event.

  6. Death, readmission because MI or stroke

    Time frame: through study completion, an average of 5 year

    death of any cause, readmission because of MI (I21) or stroke (I61-I64)

  7. Stroke (fatal or non-fatal)

    Time frame: through study completion, an average of 5 year

    readmission because of stroke (I61-I64) or death because of stroke (I61-I64)

  8. Resource use / Health care costs

    Time frame: through study completion, an average of 5 year

    Hospitalizations and investigations

  9. Re-presentation to the ED because of chest pain

    Time frame: through study completion, an average of 5 year

    Re-presentation with chest pain as the main complaint

  10. Invasive coronary angiography

    Time frame: through study completion, an average of 5 year

    Any invasive coronary angiography

  11. Non-obstructive CAD at first invasive coronary angiography

    Time frame: through study completion, an average of 5 year

    Invasive coronary angiography without any significant stenoses

  12. Angina

    Time frame: 1 year

    at least grade 1 according to Rose questionnaire

  13. Use of prevention medications

    Time frame: 1, 2 and 3 years

    Use (dispensed prescriptions) of prevention medications (antiplatelet therapy, Statins, blood pressure lowering therapy)

  14. Health-related quality of life

    Time frame: 1 year

    RAND-36: 8 domains/scales

Study contacts

Contact information is provided by the study sponsor or research team.

Henrik Löfmark, MD

CONTACT

[email protected]

Liselotte Persson, RN

CONTACT

[email protected]

+46812355000

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain

Acronym: FAST-CCTA

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2021
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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