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Coronary Artery Stent Evaluation With 320-slice Computed Tomography - The CArS 320 Study (CARS-320)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00967876
First Posted: August 28, 2009
Last Update Posted: July 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marc Dewey, Charite University, Berlin, Germany
  Purpose
The investigators aim at analyzing the diagnostic accuracy of 320-row CT for coronary stents.

Condition
Coronary Artery Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coronary Artery Stent Evaluation With 320-slice Computed Tomography - The CArS 320 Study

Further study details as provided by Marc Dewey, Charite University, Berlin, Germany:

Estimated Enrollment: 90
Study Start Date: April 2009
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent coronary artery stent placement in the past and are clinically indicated to undergo conventional coronary angiography.
Criteria

Inclusion Criteria:

  • Suspected coronary artery in-stent restenoses based on clinical findings or findings on other noninvasive imaging tests and planned coronary angiography within the next 14 days.
  • Able to understand and willing to sign the Informed CF.

Exclusion Criteria:

  • Creatinine of above 2.0 mg/dl
  • Age below 40 years
  • Women of child bearing potential (no hysterectomy, no menopause, or menopause since less than 12 months) must demonstrate a negative pregnancy test performed within 24 hours before CT.
  • Resting heart rate above 70 beats per minute and contraindications to beta blockers (e.g. moderate to severe bronchospastic disease, asthma)
  • Atrial fibrillation, uncontrolled tachycardia, A-V block II or III degree or other non-sinus rhythms
  • Inability to hold the breath for 10 seconds
  • Hypotension < 80 mmHg systolic
  • Unstable angina pectoris, acute myocardial infarction < 48h
  • Continuous therapy with Dipyridamol
  • Severe aortic stenosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967876


Locations
Germany
Charité
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Marc Dewey, MD, PhD Charité
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marc Dewey, PD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00967876     History of Changes
Other Study ID Numbers: EA1/133/08
First Submitted: August 27, 2009
First Posted: August 28, 2009
Last Update Posted: July 23, 2014
Last Verified: July 2014

Keywords provided by Marc Dewey, Charite University, Berlin, Germany:
Men or women of any ethnic group scheduled to undergo conventional coronary angiography for suspected coronary artery stent stenosis

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases