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Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain

NCT ID: NCT01770444

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

681 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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

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Chest Pain

Keywords

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Acute coronary syndrome Cardiac computed tomographic angiography Radiation dose reduction Medical radiation exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Low-dose cardiac CT

Patients randomized to this group will be assessed by low-dose cardiac CT protocol.

Group Type EXPERIMENTAL

Low-dose Cardiac CT protocol

Intervention Type OTHER

A cardiac CT protocol modified for reduction of radiation exposure

1. Prospective gating
2. Range: dedicated imaging (below carina to heart base)

Conventional cardiac CT

Patients randomized to this group will be assessed by conventional cardiac CT protocol.

Group Type OTHER

Conventional cardiac CT protocol

Intervention Type OTHER

Conventional CCTA protocol

1. Retrospective gating with tube current modulation
2. Range: dedicated imaging (below carina to heart base)

Interventions

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Low-dose Cardiac CT protocol

A cardiac CT protocol modified for reduction of radiation exposure

1. Prospective gating
2. Range: dedicated imaging (below carina to heart base)

Intervention Type OTHER

Conventional cardiac CT protocol

Conventional CCTA protocol

1. Retrospective gating with tube current modulation
2. Range: dedicated imaging (below carina to heart base)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- 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.

Exclusion Criteria

1. Known coronary artery disease and/or any related intervention (STENT, CABG)
2. Elevated cardiac biomarkers (CK-MB, Troponin I)
3. Ischemic ECG changes
4. Documented evidence of low LV systolic function (ejection fraction ≤ 45%)
5. TIMI risk \>4
6. Unstable vital sign (e.g. hypoxemia, shock)
7. Patients with contraindication to iodinated contrast and/or beta blockers including renal failure or reactive airway diseases such as COPD or asthma
8. Atrial fibrillation on initial ECGs
9. Active renal disease, serum creatinine ≥1.5 mg/dl
10. Negative coronary angiography or CCTA within 6 months
11. Modified Wells criteria \>4 or D-dimer \> 0.5ug/mL
12. Suspicious of aortic dissection or D-dimer \> 0.5ug/mL
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyuseok Kim, MD

Role: STUDY_DIRECTOR

Department of emergency medicine, Seoul national university Bundang hospital

Sangil Choi, MD

Role: STUDY_DIRECTOR

Department of radiology, Seoul national university Bundang hospital

Locations

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Seoul national university Bundang hospital

Seongnam-si, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Seoul national university Boramae medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1211/177-005

Identifier Type: -

Identifier Source: org_study_id