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

NCT00967876 | Completed

• 1 other identifier: EA1/133/08
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Stenosis

Keywords

Men or women of any ethnic group scheduled to undergo conventional coronary angiography for suspected coronary artery stent stenosis

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (7)

• 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.

  PMID: 20725881 BACKGROUND

• Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dubel 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.

  PMID: 19704093 BACKGROUND

• 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. No abstract available.

  PMID: 21273517 BACKGROUND

• 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 comparison with conventional coronary angiography. J Am Coll Cardiol. 2013 Oct 15;62(16):1476-85. doi: 10.1016/j.jacc.2013.03.088. Epub 2013 Jun 19.

  PMID: 23792193 RESULT

• Preuss D, Garcia G, Laule M, Dewey M, Rief M. Myocardial CT perfusion imaging for the detection of obstructive coronary artery disease: multisegment reconstruction does not improve diagnostic performance. Eur Radiol Exp. 2022 Jan 31;6(1):5. doi: 10.1186/s41747-021-00256-8.

  PMID: 35099638 DERIVED

• Rief M, Feger S, Martus P, Laule M, Dewey M, Schonenberger E. Acceptance of Combined Coronary CT Angiography and Myocardial CT Perfusion versus Conventional Coronary Angiography in Patients with Coronary Stents--Intraindividual Comparison. PLoS One. 2015 Sep 1;10(9):e0136737. doi: 10.1371/journal.pone.0136737. eCollection 2015.

  PMID: 26327127 DERIVED

• Feger S, Rief M, Zimmermann E, Martus P, Schuijf JD, Blobel J, Richter F, Dewey M. The Impact of Different Levels of Adaptive Iterative Dose Reduction 3D on Image Quality of 320-Row Coronary CT Angiography: A Clinical Trial. PLoS One. 2015 May 6;10(5):e0125943. doi: 10.1371/journal.pone.0125943. eCollection 2015.

  PMID: 25945924 DERIVED

MeSH Terms

Conditions

Coronary Stenosis; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Marc Dewey, MD, PhD

  Charité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2011
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

DE (1)