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

NCT ID: NCT00967876

Last Updated: 2014-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marc Dewey

PD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marc Dewey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Charité

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Charité

Berlin, State of Berlin, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20725881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19704093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21273517 (View on PubMed)

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.

Reference Type RESULT
PMID: 23792193 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35099638 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26327127 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25945924 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EA1/133/08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prediction of Atherosclerotic Plaque Progression
NCT05424705 ACTIVE_NOT_RECRUITING
Screening Of CoRonary ArTEry diSease
NCT05369728 NOT_YET_RECRUITING NA
CT-FFR-guided Strategy for In-stent Restenosis
NCT05611190 NOT_YET_RECRUITING NA