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
• 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. 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

• Coronary Artery Stenosis
• Coronary Stenosis

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