Chest PainFAST-CCTANCT04748237
Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients
A study testing Coronary computed tomopraphic angiography in people with Chest Pain and Acute Coronary Syndrome, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- Coronary computed tomopraphic angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteSweden
- Study dates
- 21 Jan 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Henrik Löfmark, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Danderyd Hospital
Stockholm, 18288
Henrik Löfmark, MD, henrik.lofmark@sll.se
Liselotte Persson, RN, liselotte.persson@sll.se
About this study
Official title: Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain
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.
Read the detailed description
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.
- Conditions
- Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease
- Being tested
- Coronary computed tomopraphic angiography
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary computed tomopraphic angiographyDiagnostic test
CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Coronary computed tomopraphic angiography | Experimental | Patients randomized to strategy including early CCTA will receive standard care according to responsible physician and referred to a CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days. Local scanning protocols can be used on ≥64-slice multi-detector CT scanners able to perform ECG-gated coronary angiography.
The coronary angiography will be classified as normal (or near normal) or as having atherosclerosis (CAD). The report will also classify each vessel (left main, prox LAD, mid or distal LAD, LCX and RCA regarding degree of stenosis (no stenosis, 0-49%, ≥50%, or not possible to estimate because of calcification or technical reason).
The result will be presented to the responsible physician as soon as possible and who will plan further care of the patients. Receives: Diagnostic Test: Coronary computed tomopraphic angiography |
| No Coronary computed tomopraphic angiography | No intervention | 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. Regardless of diagnostic strategy, the responsible physician is encouraged to initiate secondary prevention measures if the investigations indicate signs of CAD, including medication with aspirin and statins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of death, readmission because of MI or unstable angina requiring revascularization
death of any cause, readmission because of MI (I21) or revascularization because of unstable angina not related to the index event
Measured: through study completion, an average of 5 year
Secondary outcomes (14)
Death or readmission because MI
death of any cause, readmission because of MI (I21)
Measured: through study completion, an average of 5 year
Death
death of any cause
Measured: through study completion, an average of 5 year
Cardiovascular death
death because of cardiovascular cause (I00-99)
Measured: through study completion, an average of 5 year
MI (fatal or non-fatal)
readmission because of MI or death because of MI (I21)
Measured: through study completion, an average of 5 year
Readmission because of unstable angina requiring revascularization
revascularization because of unstable angina not related to the index event.
Measured: through study completion, an average of 5 year
Death, readmission because MI or stroke
death of any cause, readmission because of MI (I21) or stroke (I61-I64)
Measured: through study completion, an average of 5 year
Stroke (fatal or non-fatal)
readmission because of stroke (I61-I64) or death because of stroke (I61-I64)
Measured: through study completion, an average of 5 year
Resource use / Health care costs
Hospitalizations and investigations
Measured: through study completion, an average of 5 year
Re-presentation to the ED because of chest pain
Re-presentation with chest pain as the main complaint
Measured: through study completion, an average of 5 year
Invasive coronary angiography
Any invasive coronary angiography
Measured: through study completion, an average of 5 year
Non-obstructive CAD at first invasive coronary angiography
Invasive coronary angiography without any significant stenoses
Measured: through study completion, an average of 5 year
Angina
at least grade 1 according to Rose questionnaire
Measured: 1 year
Use of prevention medications
Use (dispensed prescriptions) of prevention medications (antiplatelet therapy, Statins, blood pressure lowering therapy)
Measured: 1, 2 and 3 years
Health-related quality of life
RAND-36: 8 domains/scales
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start21 Jan 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 coronary computed tomographic angiography or not.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tomas Jernberg, Karolinska Institutet
- Investigators
- Tomas Jernberg, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748237
- Sponsor's protocol ID
- KIDS2020-1
- Acronym
- FAST-CCTA
- Status last verified
- Aug 2024
- First submitted
- 29 Jan 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers can, after completion of study and the first report, apply for making analyses in collaboration with the steering group.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain
- ClinicalTrials.gov ID
- NCT04748237
- Acronym / sponsor ID
- FAST-CCTA / KIDS2020-1
- Conditions
- Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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 coronary computed tomographic angiography or not.
| Arm | Type | Receives |
|---|---|---|
| Coronary computed tomopraphic angiography | Experimental | Diagnostic Test: Coronary computed tomopraphic angiographyPatients randomized to strategy including early CCTA will receive standard care according to responsible physician and referred to a CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days. Local scanning protocols can be used on ≥64-slice multi-detector CT scanners able to perform ECG-gated coronary angiography. The coronary angiography will be classified as normal (or near normal) or as having atherosclerosis (CAD). The report will also classify each vessel (left main, prox LAD, mid or distal LAD, LCX and RCA regarding degree of stenosis (no stenosis, 0-49%, ≥50%, or not possible to estimate because of calcification or technical reason). The result will be presented to the responsible physician as soon as possible and who will plan further care of the patients. |
| No Coronary computed tomopraphic angiography | No intervention | –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. Regardless of diagnostic strategy, the responsible physician is encouraged to initiate secondary prevention measures if the investigations indicate signs of CAD, including medication with aspirin and statins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary computed tomopraphic angiographyCCTA as soon as possible, preferably within 24 hours, but not later than within 21 days. | Diagnostic test | Coronary computed tomopraphic angiography |
Primary outcome
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
14 secondary outcomes
Death or readmission because MI
Time frame: through study completion, an average of 5 year
Death
Time frame: through study completion, an average of 5 year
Cardiovascular death
Time frame: through study completion, an average of 5 year
MI (fatal or non-fatal)
Time frame: through study completion, an average of 5 year
Readmission because of unstable angina requiring revascularization
Time frame: through study completion, an average of 5 year
Death, readmission because MI or stroke
Time frame: through study completion, an average of 5 year
Stroke (fatal or non-fatal)
Time frame: through study completion, an average of 5 year
Resource use / Health care costs
Time frame: through study completion, an average of 5 year
Re-presentation to the ED because of chest pain
Time frame: through study completion, an average of 5 year
Invasive coronary angiography
Time frame: through study completion, an average of 5 year
Non-obstructive CAD at first invasive coronary angiography
Time frame: through study completion, an average of 5 year
Angina
Time frame: 1 year
Use of prevention medications
Time frame: 1, 2 and 3 years
Health-related quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No. Other researchers can, after completion of study and the first report, apply for making analyses in collaboration with the steering group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Löfmark, MD contact
Tomas Jernberg, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary computed tomopraphic angiography in people with Chest Pain and Acute Coronary Syndrome, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liselotte Persson, RN (+46812355000, Liselotte.Persson@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite of death, readmission because of MI or unstable angina requiring revascularization (time frame: through study completion, an average of 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.