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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marc Dewey, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00967876
First received: August 27, 2009
Last updated: July 22, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Marc Dewey, PD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00967876     History of Changes
Other Study ID Numbers: EA1/133/08
Study First Received: August 27, 2009
Last Updated: July 22, 2014
Health Authority: Germany: Federal Department for Radiation Protection

Keywords provided by 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:
Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014