Comparison Of Left Ventricular Volume And Wall Stress With Dobutamine And Exercise Echocardiography

This study has been withdrawn prior to enrollment.
(difficulty enrolling patients into this study)
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00774891
First received: October 16, 2008
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

This study will compare the physiologic responses between exercise stress echocardiography and pharmacologic stress echocardiography on left ventricular volume and wall stress.


Condition
Ischemia
Angina

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Of Left Ventricular Volume And Wall Stress With Dobutamine And Exercise Echocardiography

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Dobutamine stress echocardiography causes decrease in LV size/volume and wall stress compared to exercise stress echocardiography [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Detailed Description:

This prospective observational study will compare the physiologic responses between exercise stress echocardiography and dobutamine stress echocardiography on left ventricular volume and wall stress. Exercise and dobutamine stress testing are two widely employed diagnostic modalities that are often used, interchangeably, to detect inducible ischemia. We hypothesize that dobutamine leads to significantly lower ventricular volumes and wall stress than exercise.

Some previous studies have shown that dobutamine and exercise echocardiography have comparable sensitivities and specificities, differences exist between the hemodynamic effects produced by each modality on the cardiovascular system. These variable effects may lead to differences in left ventricular size, volume and wall stress. If divergent left ventricular effects exist(between exercise and dobutamine induced stress), then the degree of myocardial oxygen consumption, ischemic burden, and ischemic threshold observed during exercise and dobutamine stress testing may be different between these commonly used modalities of stress testing.

The potentially variable effects on the left ventricle in response to the modality used to induce stress would highlight a physiological difference between exercise and dobutamine stress testing. Differences in volumes and stress could also help explain the greater of ischemia and higher frequency of angina and ST-segment deviation which has been previously observed in some studies during exercise as compared to dobutamine echocardiography. The presence or lack of these expected hemodynamic responses may also have additional diagnostic and prognostic implications.

The study involves the collection of data among patients undergoing stress echocardiograms that are clinically indicated. This data will be retrieved from the echocardiogram and report and medical chart, including baseline clinical characteristics, exercise parameters achieved during the test.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Lahey Clinic patients referred by their physician for stress echocardiograms for clinical indications. Approximately 30 patients referred for an exercise stress echocardiography and approximately 30 patients referred for a dobutamine stress echocardiography.

Criteria

Inclusion Criteria:

  • Age 30-80 years
  • Normal sinus rhythm on electrocardiogram
  • Normal left ventricular systolic function on baseline echocardiogram

Exclusion Criteria:

  • Patients with stress-induced wall motion abnormalities
  • Left ventricular hypertrophy
  • Evidence of prior myocardial infarction
  • More than mild valvular heart disease
  • Prior cardiac surgery
  • Poor technical quality of echocardiogram
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774891

Locations
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Sherif B. Labib, M.D. Lahey Clinic, Inc.
  More Information

Publications:

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00774891     History of Changes
Other Study ID Numbers: 2008-091
Study First Received: October 16, 2008
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Echocardiography- exercise
Echocardiography- dobutamine
Wall stress
Ventricular volume-left
Ischemia
Angina
Heart diseases
Stress echocardiography
Ventricular volume
Wall Stress
Vascular diseases

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on April 16, 2014