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Chest Pain SyndromePhase 4CAPTURENCT01067456

Comprehensive Cardiothoracic Dual Source CT for the Early Triage of Patients With Acute Chest Pain

A Phase 4 study testing Comprehensive Cardiothoracic CT arm in people with Chest Pain Syndrome, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research is to determine the efficiency of a single dual source computed tomography (CT-DSCT) protocol to establish or exclude acute coronary syndrome (ACS), pulmonary embolism (PE) or aortic dissection (AD) as compared to the individual protocols. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Chest Pain Syndrome
What is being tested?
Comprehensive Cardiothoracic CT arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
May 2008to Jan 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females >30 years of age in sinus rhythm
  • Willing and able to provide written informed consent
  • Undifferentiated chest discomfort or shortness of breath with a component of chest discomfort within the last 24 hours
  • Intermediate likelihood of MI, pulmonary embolism (PE), or aortic dissection (AD) as determined by ED providers after completion of standard initial clinical evaluation
  • ED providers independently decide that the patient's care plan should include a coronary, PE, or AD CT.
  • Female patients must be either of non-childbearing potential (i.e., surgically sterilized or post menopausal [≥ 12 consecutive months without menses]) or must have a negative pregnancy test

Who cannot join

  • Positive cardiac biomarkers (elevated serum creatine phosphate (CK) with elevated CK-MB isoform and/or elevated troponin)
  • Diagnostic ECG changes (e.g., >1 mm ST-segment elevation or depression in two anatomically contiguous leads)
  • Known history of CAD (i.e., past myocardial infarction, prior coronary stent Placement, and/or coronary artery bypass graft surgery)
  • Known history of thoracic aortic disease (i.e., thoracic aortic aneurysm > 5cm in diameter, history of aortic dissection, and/or history of thoracic aortic aneurysm repair (via open surgery or stent-graft placement))
  • Known history of pulmonary embolism
  • Heart rate > 100 beats per minute
Show all 12Show fewer
  • Systolic blood pressure <105 mmHg
  • Oxygen saturation < 90%
  • Any cardiac arrhythmia causing hemodynamic compromise
  • Serum creatinine clearance <60 mL/min by Cockcroft-Gault
  • Known allergy to iodinated contrast agents
  • Subjects on metformin therapy that are unable or unwilling to discontinue therapy for 48 hours after CT procedure

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Diagnostic Value of Comprehensive Cardiothoracic Dual Source CT for the Early Triage of Patients With Undifferentiated Acute Chest Pain

The purpose of this research is to determine the efficiency of a single dual source computed tomography (CT-DSCT) protocol to establish or exclude acute coronary syndrome (ACS), pulmonary embolism (PE) or aortic dissection (AD) as compared to the individual protocols. Endpoints aim to compare the rate of emergency department (ED) discharge, length of hospital stay, the diagnostic imaging test utilization, and the costs between the comprehensive and the standard protocol strategy in patients with undifferentiated chest discomfort or shortness of breath with a component of chest discomfort.

Read the detailed description

Undifferentiated chest pain is one of the most common complaints in the acute care setting, accounting for over five million emergency department (ED) visits in the U.S. each year. Moreover, early and accurate triage of these patients remains difficult as neither the chest pain history, a single set of biochemical markers for myocardial necrosis, or the initial 12-lead electrocardiogram (ECG), alone or in combination, identify a group of patients that can be safely discharged without further diagnostic testing. As a result, patients presenting to the ED with undifferentiated chest pain are often evaluated with multiple examinations to exclude the presence of myocardial infarction (MI),pulmonary embolism (PE), and/or aortic dissection (AD).

While contrast-enhanced spiral computed tomography angiography (CTA) has become a standard procedure in the evaluation of the presence of PE and AD, it was only within the past few years that noninvasive detection of coronary artery stenosis with CTA has become feasible. Coronary CTA has been proven to be an effective tool to rule out CAD with reported sensitivities of 93-99% and specificities of 95-97% as compared to invasive coronary angiography.

Recent data from our Rule Out Myocardial Infarction by Computer Assisted Tomography (ROMICAT) study indicates that coronary CTA accurately rules out acute coronary syndrome (ACS) in patients with acute chest pain and therefore may enhance the diagnostic work up of chest pain patients in the ED. Moreover, this study demonstrated the distribution of several CT-angiographic patterns of CAD which may change management of subjects with inconclusive initial ED evaluation admitted to the hospital. For example, CTA demonstrated the absence of any CAD in 50% of the patients. None of the subjects without any CAD on CTA developed unstable angina or had an MI during index hospitalization. Furthermore, none of these patients had any MACE over the next six months, confirming previous observations in ACS patients. These data suggest that 50% of hospital admissions could be saved. Another recent study our group has demonstrated that an individually tailored ECG-gated CT protocol with a single contrast injection permits simultaneous visualization of the coronary arteries, thoracic aorta, and pulmonary arteries with excellent image quality.

The very recent introduction of dual source CT (DSCT) technology offers a two-fold improvement in temporal resolution as compared to the standard 64-slice CTA that was used for these studies (83ms vs. 165ms, respectively). This significant improvement in temporal resolution allows for the acquisition of diagnostic images with higher and irregular heart rates, precluding the need for intravenous beta blockade. Given the improved temporal resolution and faster acquisition time, the amount of radiation exposure can be markedly reduced in many patients.

With the need to improve triage of patients with undifferentiated chest pain and the advantages offered by DSCT technology, several observational case series have suggested the feasibility of a comprehensive thoracic DSCT (CT-DSCT) to simultaneously evaluate the coronary arteries, thoracic aorta, and pulmonary arteries. Whether this will result in an improvement of patient management and test utilization remains unclear as compared to a standard ED evaluation protocol needs to be evaluated.

Thus, the purpose of this research is to determine the efficiency of a single CT-DSCT protocol to establish or exclude MI, PE, or AD as compared to the individual protocols. Endpoints aim to compare the rate of ED discharge, length of hospital stay, the diagnostic imaging test utilization, and the costs between the comprehensive and the standard protocol strategy in patients with undifferentiated chest discomfort or shortness of breath with a component of chest discomfort.

Being tested
Comprehensive Cardiothoracic CT arm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive Cardiothoracic CT armRadiation

    Subjects in this arm will receive the comprehensive cardiothoracic CT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan.

Study groups in NCT01067456
Study groupRoleWhat they receive
Dedicated CT armNo interventionSubjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
Comprehensive Cardiothoracic CT armExperimentalThe intervention consisted in a change of the routine CT protocol (as in dedicated CT protocol) to a comprehensive cardiothoracic CT protocol which includes changes in contrast injection and coverage to enable evaluation of the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
Receives: Radiation: Comprehensive Cardiothoracic CT arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of Hospital Stay

    Measured: Index Hospitalization (within 48 hours)

Secondary outcomes (2)
  1. Direct Hospital Discharge Without Imaging

    Number of patients discharged without imaging

    Measured: Index Hospitalization (within 48 hours)

  2. Cost of Care

    Cost of stay in USD

    Measured: Index Hospitalization (within 48 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2010 (estimated)
  2. Study startMay 2008
  3. Primary completionJun 2009
  4. Study completionJan 2010

Resources

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 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized diagnostic trial, two arms
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01067456
Sponsor's protocol ID
2008P000389
Acronym
CAPTURE
Status last verified
Nov 2017
First submitted
10 Feb 2010
Last updated
22 Dec 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Comprehensive Cardiothoracic CT arm in people with Chest Pain Syndrome, run by Massachusetts General Hospital at 1 site in United States.

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 6 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 22 Dec 2017. 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 United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Length of Hospital Stay (time frame: Index Hospitalization (within 48 hours)). 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 22 Dec 2017.

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