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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Mori Krantz, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01572220
First received: April 3, 2012
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Chest Pain
Symptomatic Ischemic Equivalent
Other: UCA stress echocardiography or myocardial SPECT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Stress Echo Ultrasound Contrast in an Urban Safety Net Hospital to Refine Ischemia Evaluation

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Rate of non-diagnostic tests between ultrasound contrast enhanced stress echocardiography and myocardial SPECT [ Time Frame: Within 5 days of stress imaging ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Similarity in rates of cardiac catheterization and acute coronary syndrome events between UCA stress echocardiography and myocardial SPECT [ Time Frame: by 30 +/- 7 days post-discharge ] [ Designated as safety issue: No ]
    • 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

  • Shorter length of stay and lower cost of inpatient hospital care for UCA stress echocardiography than for myocardial SPECT [ Time Frame: 30 day assesment ] [ Designated as safety issue: No ]
    • 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

  • Greater physician satisfaction when using UCA stress echocardiography than for myocardial SPECT [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    •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.


Enrollment: 240
Study Start Date: April 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
stress echocardiography
Comparative effectiveness
Other: UCA stress echocardiography or myocardial SPECT
Comparative Effectiveness of cardiac stress imaging modalities
Myocardial SPECT
CER
Other: UCA stress echocardiography or myocardial SPECT
Comparative Effectiveness of cardiac stress imaging modalities

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

    1. Males or females aged ≥ 18 years
    2. Evaluated for symptoms of chest discomfort or ischemic equivalent
    3. 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
      • High pretest probability of CAD regardless of ECG interpretability and ability to exercise
    4. Willing and able to provide written informed consent to participate in this study
    5. 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

Exclusion Criteria:

  • Patients who meet any of the following exclusion criteria are not to be enrolled in this study:

    1. 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
      • 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%)
    2. 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
    3. 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
    4. Uncontrolled hypertension defined as systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg at screening
    5. Hemoglobin (Hb) < 7.5 mg/dL at screening or within 3 months prior to screening
    6. 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
    7. Females who are pregnant or nursing
    8. Known intolerance to any of the study stress agents (dipyridamole, dobutamine) or study cardiac imaging agents (Optison, Cardiolite)
    9. Weight ≥ 350lbs
    10. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572220

Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
General Electric
Investigators
Principal Investigator: Mori Krantz, MD FACC FACP Denver Health Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Mori Krantz, Principal Investigator, Cardiologist, MD FACC FACP, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01572220     History of Changes
Other Study ID Numbers: 12-0009
Study First Received: April 3, 2012
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:
Hospitalized patients

Additional relevant MeSH terms:
Chest Pain
Ischemia
Pain
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014