Computed Tomography Angiography Prediction Score for Percutaneous Revascularization of Chronic Total Occlusions

NCT02022878 | Completed

• 1 other identifier: NP-0021-106/1416/13
• Study Type: observational
• Target: 229
• Locations: 2 countries
• Sites: 4

Brief Summary

Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing coronary angiography. The presence of an untreated CTO has been related to adverse clinical prognosis, both in stable angina and acute myocardial infarction, and is often associated with persistent symptomatic angina. Depending on their symptomatic and functional status as well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy combined with coronary revascularization. The potential benefits of percutaneous coronary intervention (PCI) in CTO include symptom relief, improved left ventricular function, and potentially a survival advantage associated with success when compared with failed revascularization. Of note, marked advances in endovascular techniques and device technology have resulted in substantial improvements of procedural success rates of PCI in CTO. In spite of these advances, the vast majority of patients with CTO are still being managed medically or referred for coronary bypass surgery rather than PCI. The most common reason for deferring PCI in patients with CTO appears to be the uncertainty of predicting the procedural outcome of percutaneous revascularization. Further barriers to attempting CTO by PCI include the difficulty of gauging the time required for the procedure and the use of resources. The CT-RECTOR (Computed Tomography REgistry of Chronic Total Occlusion Revascularization) study was designed to evaluate the application of coronary computed tomography angiography (CTA) for the prediction of procedural outcome of PCI in CTO in an international patient population. The main purpose of this multicenter registry is to develop a noninvasive CTA-based prediction tool (CT-RECTOR Score) for grading CTO suitability for PCI.

Conditions

Coronary Artery Disease

Keywords

Chronic total occlusion; Percutaneous coronary intervention; Coronary computed tomography angiography; Coronary angiography

Outcome Measures

Primary Outcomes (1)

• Successful guidewire crossing through CTO within 30 min

  Successful guidewire crossing through CTO within 30 min (defined as the time from initial insertion of the guidewire into the coronary lumen to the time it was successfully crossed through the lesion or was pulled out of the lumen because of unsuccessful guidewire crossing)

  Intraprocedural

Secondary Outcomes (2)

• Successful guidewire crossing through CTO and restoration of flow

  Intraprocedural

• Successful guidewire crossing through CTO with implantation of stent and restoration of flow

  Intraprocedural

Study Arms (1)

Attempted PCI of CTO

Attempted PCI of CTO with preprocedural coronary CTA scan

Procedure: PCI of CTO

Interventions

PCI of CTO PROCEDURE

Attempted PCI of CTO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of patients at multiple international centers undergoing preprocedural coronary CTA before attempted PCI of CTO between 2007 and 2013.

You may qualify if:

• Patients referred for attempted PCI of CTO as part of their standard of care
• Performance of coronary CTA with 64-detector rows or greater within 6 weeks before attempted PCI of CTO
• Native vessel or bypass graft de novo or in-stent restenosis CTO
• Angiographically defined CTO with TIMI flow 0 and estimated duration over 3 months (the duration of the occlusion was determined based on either a history of sudden chest pain, a previous myocardial infarction in the same target vessel territory, or the time between the diagnosis made from coronary angiography and subsequent PCI)

You may not qualify if:

• Age \<18 years

Sponsors & Collaborators

• Kerckhoff Heart Center: lead
• University of Giessen: collaborator
• University Hospital Erlangen: collaborator
• National Institute of Cardiology, Warsaw, Poland: collaborator

Study Sites (4)

Kerckhoff Heart Center

Bad Nauheim, 61231, Germany

Location

University Clinic Erlangen

Erlangen, 91054, Germany

Location

University Clinic Giessen and Marburg

Giessen, 35392, Germany

Location

Institute of Cardiology

Warsaw, 04628, Poland

Location

Related Publications (1)

• Opolski MP, Achenbach S, Schuhback A, Rolf A, Mollmann H, Nef H, Rixe J, Renker M, Witkowski A, Kepka C, Walther C, Schlundt C, Debski A, Jakubczyk M, Hamm CW. Coronary computed tomographic prediction rule for time-efficient guidewire crossing through chronic total occlusion: insights from the CT-RECTOR multicenter registry (Computed Tomography Registry of Chronic Total Occlusion Revascularization). JACC Cardiovasc Interv. 2015 Feb;8(2):257-267. doi: 10.1016/j.jcin.2014.07.031.

  PMID: 25700748 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Christian W. Hamm, Prof. Dr.

  Kerckhoff Heart Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiology Department

Study Record Dates

• First Submitted: December 22, 2013
• First Posted: December 30, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

DE (3); PL (1)