Chest PainNCT01770444
Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain
A study testing Low-dose Cardiac CT protocol and Conventional cardiac CT protocol in people with Chest Pain, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
This study is to see whether the low-dose coronary computed tomographic angiography (CCTA) protocol is as safe and efficacious as conventional-dose protocol in early triage of acute chest pain. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Chest Pain
- What is being tested?
- Low-dose Cardiac CT protocol and Conventional cardiac CT protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 681 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Dec 2012to Apr 2016
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients visiting emergency department for A) acute onset (<12hr) chest pain or equivalent symptoms B) aged between 25-55, C) that requires to rule out acute coronary syndrome.
Who cannot join
- Known coronary artery disease and/or any related intervention (STENT, CABG)
- Elevated cardiac biomarkers (CK-MB, Troponin I)
- Ischemic ECG changes
- Documented evidence of low LV systolic function (ejection fraction ≤ 45%)
- TIMI risk >4
- Unstable vital sign (e.g. hypoxemia, shock)
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- Patients with contraindication to iodinated contrast and/or beta blockers including renal failure or reactive airway diseases such as COPD or asthma
- Atrial fibrillation on initial ECGs
- Active renal disease, serum creatinine ≥1.5 mg/dl
- Negative coronary angiography or CCTA within 6 months
- Modified Wells criteria >4 or D-dimer > 0.5ug/mL
- Suspicious of aortic dissection or D-dimer > 0.5ug/mL
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul national university Bundang hospital
Seongnam-si, 463-707
Asan Medical Center
Seoul, 138-736
Seoul national university Boramae medical center
Seoul, 156-707
About this study
Official title: Safety and Efficacy of Implementing Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain in Emergency Department
This study is to see whether the low-dose coronary computed tomographic angiography (CCTA) protocol is as safe and efficacious as conventional-dose protocol in early triage of acute chest pain.
Read the detailed description
Currently, CCTA is a valuable tool for early triage of low to intermediate risk acute chest pain patients in emergency department. However, it has been criticized for causing unnecessary radiation exposure in the population where its majority has no coronary lesion. A low-dose CCTA protocol comprised with 1) dedicated cardiac imaging protocol (rather than triple rule-out protocol), 2) prospective gating and 3) without additional imaging for calcium scoring will be used to implement the low-dose imaging. We hypothesized that the low-dose CCTA protocol will be as safe and efficacious as conventional dose protocol while decreasing the amount of radiation exposure significantly.
- Conditions
- Chest Pain
- Being tested
- Low-dose Cardiac CT protocol, Conventional cardiac CT protocol
- Keywords
- Acute coronary syndrome, Cardiac computed tomographic angiography, Radiation dose reduction, Medical radiation exposure
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose Cardiac CT protocolOther
A cardiac CT protocol modified for reduction of radiation exposure
- Prospective gating
- Range: dedicated imaging (below carina to heart base)
Conventional cardiac CT protocolOther
Conventional CCTA protocol
- Retrospective gating with tube current modulation
- Range: dedicated imaging (below carina to heart base)
| Study group | Role | What they receive |
|---|---|---|
| Low-dose cardiac CT | Experimental | Patients randomized to this group will be assessed by low-dose cardiac CT protocol. Receives: Other: Low-dose Cardiac CT protocol |
| Conventional cardiac CT | Other | Patients randomized to this group will be assessed by conventional cardiac CT protocol. Receives: Other: Conventional cardiac CT protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings
Measured: Within one month after discharge from emergency department
Secondary outcomes (4)
Direct comparison of accuracy (sensitivity, specificity, PPV, NPV) for between low-dose and conventional cardiac CT
The diagnostic accuracy of detecting ACS will be assessed using patient chart review and telephone interview (48-72 hours and one month after discharge) as appropriate. ACS event (and MACE) will be adjudicated by independent cardiologists.
Measured: One month after discharge from emergency department
Direct comparison of frequency and overall cost of additional tests such as echocardiography, treadmill test, myocardial SPECT and coronary angiography
Measured: During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge
Total radiation dose exposed by index CT imaging and additional tests including SPECT and invasive angiography
Measured: During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge
Total length of ED and hospital stay
Measured: Time spent for index ED visit, which will be an average of 24 hours and total hospital stay until discharge, which will be an average of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2016
- Study completionApr 2016
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 Seoul National University HospitalThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 681 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyuseok Kim, MD, Study director, Department of emergency medicine, Seoul national university Bundang hospitalSangil Choi, MD, Study director, Department of radiology, Seoul national university Bundang hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770444
- Sponsor's protocol ID
- B-1211/177-005
- Status last verified
- Nov 2015
- First submitted
- 20 Dec 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Implementing Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain in Emergency Department
- ClinicalTrials.gov ID
- NCT01770444
- Acronym / sponsor ID
- B-1211/177-005
- Conditions
- Chest Pain
- Keywords
- Acute coronary syndrome, Cardiac computed tomographic angiography, Radiation dose reduction, Medical radiation exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 681 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Jan 2013 (estimated)
- 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.
This study is to see whether the low-dose coronary computed tomographic angiography (CCTA) protocol is as safe and efficacious as conventional-dose protocol in early triage of acute chest pain.
Detailed description
Currently, CCTA is a valuable tool for early triage of low to intermediate risk acute chest pain patients in emergency department. However, it has been criticized for causing unnecessary radiation exposure in the population where its majority has no coronary lesion. A low-dose CCTA protocol comprised with 1) dedicated cardiac imaging protocol (rather than triple rule-out protocol), 2) prospective gating and 3) without additional imaging for calcium scoring will be used to implement the low-dose imaging. We hypothesized that the low-dose CCTA protocol will be as safe and efficacious as conventional dose protocol while decreasing the amount of radiation exposure significantly.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose cardiac CT | Experimental | Other: Low-dose Cardiac CT protocolPatients randomized to this group will be assessed by low-dose cardiac CT protocol. |
| Conventional cardiac CT | Other | Other: Conventional cardiac CT protocolPatients randomized to this group will be assessed by conventional cardiac CT protocol. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients visiting emergency department for A) acute onset (<12hr) chest pain or equivalent symptoms B) aged between 25-55, C) that requires to rule out acute coronary syndrome.
Key exclusion criteria (12 listed)
- Known coronary artery disease and/or any related intervention (STENT, CABG)
- Elevated cardiac biomarkers (CK-MB, Troponin I)
- Ischemic ECG changes
- Documented evidence of low LV systolic function (ejection fraction ≤ 45%)
- TIMI risk >4
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 |
|---|---|---|
| Low-dose Cardiac CT protocolA cardiac CT protocol modified for reduction of radiation exposure 1. Prospective gating 2. Range: dedicated imaging (below carina to heart base) | Other | Low-dose cardiac CT |
| Conventional cardiac CT protocolConventional CCTA protocol 1. Retrospective gating with tube current modulation 2. Range: dedicated imaging (below carina to heart base) | Other | Conventional cardiac CT |
Primary outcome
Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings
Time frame: Within one month after discharge from emergency department
4 secondary outcomes
Direct comparison of accuracy (sensitivity, specificity, PPV, NPV) for between low-dose and conventional cardiac CT
Time frame: One month after discharge from emergency department
Direct comparison of frequency and overall cost of additional tests such as echocardiography, treadmill test, myocardial SPECT and coronary angiography
Time frame: During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge
Total radiation dose exposed by index CT imaging and additional tests including SPECT and invasive angiography
Time frame: During 1) index ED visit, which will be an average of 1 day and 2) one-month follow-up period after discharge
Total length of ED and hospital stay
Time frame: Time spent for index ED visit, which will be an average of 24 hours and total hospital stay until discharge, which will be an average of 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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.
Kyuseok Kim, MD study director
Department of emergency medicine, Seoul national university Bundang hospital
Sangil Choi, MD study director
Department of radiology, Seoul national university Bundang hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose Cardiac CT protocol and Conventional cardiac CT protocol in people with Chest Pain, run by Seoul National University Hospital at 3 sites in South Korea.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients having hard events (death, MI) after negative low-dose CCTA findings (time frame: Within one month after discharge from emergency department). 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 2 Nov 2016.