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

NCT ID: NCT02022878

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 229 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-06-30

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.

Detailed Description

Coronary CTA has recently emerged as a valuable noninvasive tool to provide guidance during percutaneous treatment of CTO. The main advantages of coronary CTA in characterization of CTO include the 3-dimensional visualization of occlusion trajectory and morphology as well as the exact evaluation of calcifications. Despite this, and although prior single-center studies suggested a potential utility of individual coronary CTA-based CTO characteristics for predicting PCI, there has been no compiled prediction model for grading CTO suitability for PCI in a large cohort of patients.

The CT-RECTOR registry is a retrospective, multicenter observational study of patients undergoing preprocedural coronary CTA before attempted PCI of CTO between 2007 and 2013. The study was designed to enroll 250 consecutive patients at 4 high-volume cluster sites in 2 European countries. CT-RECTOR sites were chosen on the basis of adequate coronary CTA volume and PCI proficiency to reflect the state-of-the-art, ''real-life'' management of patients with CTO.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Attempted PCI of CTO

Attempted PCI of CTO with preprocedural coronary CTA scan

PCI of CTO

Intervention Type: PROCEDURE

Interventions

PCI of CTO

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Age <18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Giessen

OTHER

Sponsor Role: collaborator

University Hospital Erlangen

OTHER

Sponsor Role: collaborator

National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role: collaborator

Kerckhoff Heart Center

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Christian W. Hamm

Director, Cardiology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian W. Hamm, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff Heart Center

Locations

Kerckhoff Heart Center

Bad Nauheim, , Germany

University Clinic Erlangen

Erlangen, , Germany

University Clinic Giessen and Marburg

Giessen, , Germany

Institute of Cardiology

Warsaw, , Poland

Countries

Germany; Poland

References

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.

Reference Type: DERIVED

PMID: 25700748 (View on PubMed)

Other Identifiers

NP-0021-106/1416/13

Identifier Type: -

Identifier Source: org_study_id