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AzTrials

Chest PainSECURENCT01572220

Stress Echo Ultrasound Contrast in an Urban Safety Net Hospital to Refine Ischemia Evaluation

A study testing UCA stress echocardiography or myocardial SPECT in people with Chest Pain and Symptomatic Ischemic Equivalent, run by Denver Health and Hospital Authority 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 current study is designed to have broad generalizability and inform a potential shift toward greater utilization of stress echocardiography with UCA. This will be accomplished by comparing UCA stress echocardiography with myocardial SPECT among hospitalized patients presenting with atraumatic chest pain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chest Pain, Symptomatic Ischemic Equivalent
What is being tested?
UCA stress echocardiography or myocardial SPECT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
Apr 2012to Oct 2017
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

  • Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
  • Males or females aged ≥ 18 years
  • Evaluated for symptoms of chest discomfort or ischemic equivalent
  • Clinical indication for stress imaging, defined as one of the following clinical risk estimates for CAD based upon the Diamond and Forrester classification7:
  • Intermediate pretest probability of CAD and electrocardiogram (ECG) is clinically interpretable and patient is able to exercise
  • Intermediate pretest probability of CAD and ECG is clinically interpretable or patient is unable to exercise
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  • High pretest probability of CAD regardless of ECG interpretability and ability to exercise
  • Willing and able to provide written informed consent to participate in this study
  • Agrees to remain under observation (e.g., inpatient or observational status) until all study procedures from the hospital stay are completed, and to complete a 30-day follow up call

Who cannot join

  • Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
  • Documented medical history or discovery during screening and/or admission of any of the following:
  • Severe aortic or mitral stenosis
  • Significant resting left ventricular outflow tract obstruction (velocity > 3 cm/s)
  • Mobile left ventricular apical thrombus
  • Acute pericarditis or pericardial tamponade
Show all 21Show fewer
  • Ascending or thoracic aortic aneurysm that is not stable or meets surgical criteria
  • Acute decompensated congestive heart failure
  • Established severe left ventricular systolic dysfunction (left ventricular ejection fraction < 35%)
  • Definite acute coronary syndrome (e.g., unstable angina, acute myocardial infarction) as confirmed by elevated Troponin I (>0.6 ng/L) on two successive measurements or ECG changes diagnostic for unstable angina (e.g. localized ST changes) in conjunction with clinical appraisal
  • Any of the following other abnormalities on the ECG at screening:
  • Paced ventricular rhythm or complete left bundle branch block
  • Uncontrolled arrhythmias defined by frequent premature ventricular complexes (PVCs) > 10/minute, non-sustained ventricular tachycardia, or atrial fibrillation with rapid ventricular response
  • 2nd or 3rd degree heart block
  • Uncontrolled hypertension defined as systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg at screening
  • Hemoglobin (Hb) < 7.5 mg/dL at screening or within 3 months prior to screening
  • Potassium < 3.0 mmol/L or > 5.5 mmol/L or severe electrolyte abnormality at screening that, in the opinion of the supervising physician or Investigator, makes stress testing unsafe
  • Females who are pregnant or nursing
  • Known intolerance to any of the study stress agents (dipyridamole, dobutamine) or study cardiac imaging agents (Optison, Cardiolite)
  • Weight ≥ 350lbs
  • Any physical or psychological condition that, in the opinion of the Investigator, may adversely affect the safety of the patient if enrolled in this trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Denver Health Medical Center

    Denver, Colorado, 80204

Other trials in United States

About this study

The current study is designed to have broad generalizability and inform a potential shift toward greater utilization of stress echocardiography with UCA. This will be accomplished by comparing UCA stress echocardiography with myocardial SPECT among hospitalized patients presenting with atraumatic chest pain. This study seeks to demonstrate: clinical comparability of the 2 modalities (based on non-diagnostic test rates), improved care efficiency (based on length of stay), lower costs, improved provider satisfaction, and a presumed improved safety profile through the elimination of radiation exposure.

Primary Hypothesis: A strategy of routine UCA (Optison™) enhanced stress echocardiography will result in a clinically non-diagnostic test rate comparable to myocardial SPECT among patients hospitalized (inpatient or hospital observation status) with atraumatic chest pain.

Being tested
UCA stress echocardiography or myocardial SPECT
Keywords
Hospitalized patients
Medical subject headings
Chest Pain

What participants receive

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

  • UCA stress echocardiography or myocardial SPECTOther

    Comparative Effectiveness of cardiac stress imaging modalities

Study groups in NCT01572220
Study groupRoleWhat they receive
stress echocardiographyOtherComparative effectiveness
Receives: Other: UCA stress echocardiography or myocardial SPECT
Myocardial SPECTOtherCER
Receives: Other: UCA stress echocardiography or myocardial SPECT

What is being measured

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

  1. Rate of non-diagnostic tests between ultrasound contrast enhanced stress echocardiography and myocardial SPECT

    Non-diagnostic test rates will be the principal outcome of interest and are defined as those studies that do not allow a clinical decision for patient disposition (alternative non-invasive modality ordered, imaging inadequate to exclude ischemia, target heart rate not achieved, adverse side effects and test was terminated, discharge, further invasive testing such as coronary angiography) or require cardiology consultation for further evaluation.

    Measured: Within 5 days of stress imaging

Secondary outcomes (3)

  1. Similarity in rates of cardiac catheterization and acute coronary syndrome events between UCA stress echocardiography and myocardial SPECT

    • 30-day rates of cardiac catheterization between the two imaging modalities
    • Difference in the 30-day composite rate of acute coronary syndrome re-hospitalization, revascularization, and death between the two imaging modalities
    • Similarity in positive predictive value (PPV) of the two imaging modalities
    • Inter-rater reliability estimates for non-diagnostic echocardiogram studies

    Measured: by 30 +/- 7 days post-discharge

  2. Shorter length of stay and lower cost of inpatient hospital care for UCA stress echocardiography than for myocardial SPECT

    • Length of inpatient hospital stay of UCA stress echocardiography versus myocardial SPECT
    • Difference in time-to-cardiac catheterization beginning from time of admission
    • Differences in time-to-stress test completion beginning from time of admission30-day hospital costs of UCA stress echocardiography versus myocardial SPECT

    Measured: 30 day assesment

  3. Greater physician satisfaction when using UCA stress echocardiography than for myocardial SPECT

    •Physician satisfaction as assessed on questionnaire with UCA stress echocardiography versus myocardial SPECT. Physician(s) will be the provider(s) who supervised patient care during inpatient hospital stay.

    Measured: 5 days

Timeline

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

  1. First posted6 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2014
  4. Study completionOct 2017

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 N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01572220
Sponsor's protocol ID
12-0009
Acronym
SECURE
Status last verified
Dec 2017
First submitted
3 Apr 2012
Last updated
11 Dec 2017
Results posted
No
Data monitoring committee
No

Publications

  • Garber AM, Solomon NA. Cost-effectiveness of alternative test strategies for the diagnosis of coronary artery disease. Ann Intern Med. 1999 May 4;130(9):719-28. doi: 10.7326/0003-4819-130-9-199905040-00003.

    PubMed 10357690

  • Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.

    PubMed 20008689

  • Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, Shah ND, Nasir K, Einstein AJ, Nallamothu BK. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med. 2009 Aug 27;361(9):849-57. doi: 10.1056/NEJMoa0901249.

    PubMed 19710483

  • Kisacik HL, Ozdemir K, Altinyay E, Oguzhan A, Kural T, Kir M, Kutuk E, Goksel S. Comparison of exercise stress testing with simultaneous dobutamine stress echocardiography and technetium-99m isonitrile single-photon emission computerized tomography for diagnosis of coronary artery disease. Eur Heart J. 1996 Jan;17(1):113-9. doi: 10.1093/oxfordjournals.eurheartj.a014669.

    PubMed 8682117

  • Diamond GA, Forrester JS. Analysis of probability as an aid in the clinical diagnosis of coronary-artery disease. N Engl J Med. 1979 Jun 14;300(24):1350-8. doi: 10.1056/NEJM197906143002402.

    PubMed 440357

  • Salame G, Juselius WE, Burden M, Long CS, Bendelow T, Beaty B, Masoudi FA, Krantz MJ. Contrast-Enhanced Stress Echocardiography and Myocardial Perfusion Imaging in Patients Hospitalized With Chest Pain: A Randomized Study. Crit Pathw Cardiol. 2018 Jun;17(2):98-104. doi: 10.1097/HPC.0000000000000141.

    PubMed 29768319

Questions about this trial

What is this clinical trial studying?

A study testing UCA stress echocardiography or myocardial SPECT in people with Chest Pain and Symptomatic Ischemic Equivalent, run by Denver Health and Hospital Authority 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 9 inclusion and 21 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 11 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.

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?

Rate of non-diagnostic tests between ultrasound contrast enhanced stress echocardiography and myocardial SPECT (time frame: Within 5 days of stress imaging). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01572220, which also lists 6 linked publications.

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 11 Dec 2017.

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