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NCT00967876 Clinical Trial

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

Coronary Artery Stenosis Clinical Trial

— CARS-320  

Official title:
Coronary Artery Stent Evaluation With 320-slice Computed Tomography - The CArS 320 Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00967876
Other study ID # EA1/133/08
Secondary ID
Status Completed
Phase N/A
First received August 27, 2009
Last updated July 22, 2014
Start date April 2009

Study information
Verified date July 2014
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Department for Radiation Protection
Study type Observational

Clinical Trial Summary

The investigators aim at analyzing the diagnostic accuracy of 320-row CT for coronary stents.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Charité Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dübel HP, Schlattmann P, Knebel F, Rutsch W, Hamm B. Noninvasive coronary angiography by 320-row computed tomography with lower radiation exposure and maintained diagnostic accuracy: comparison of results with cardiac catheterization in a head-to-head pilot investigation. Circulation. 2009 Sep 8;120(10):867-75. doi: 10.1161/CIRCULATIONAHA.109.859280. Epub 2009 Aug 24. — View Citation

Dewey M. Coronary CT versus MR angiography: pro CT--the role of CT angiography. Radiology. 2011 Feb;258(2):329-39. doi: 10.1148/radiol.10100161. Review. — View Citation

Rief M, Zimmermann E, Stenzel F, Martus P, Stangl K, Greupner J, Knebel F, Kranz A, Schlattmann P, Laule M, Dewey M. Computed tomography angiography and myocardial computed tomography perfusion in patients with coronary stents: prospective intraindividual — View Citation

Zimmermann E, Dewey M. Whole-heart 320-row computed tomography: reduction of radiation dose via prior coronary calcium scanning. Rofo. 2011 Jan;183(1):54-9. doi: 10.1055/s-0029-1245629. Epub 2010 Aug 19. — View Citation

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