Clinical trial NCT01205425: Computed Tomography Coronary Angiography Before Stent Implantation
Official title: Role of Computed Tomography Coronary Angiography in Optimalization of Percutaneous Coronary Interventions With Stent Implantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Coronary Artery Disease
Keywords: Computed coronary angiography
Stent implantation
IVUS
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Ministerstwo Nauki i Szkolnictwa Wyższego, Warszawa, Polska
First posted: 2010-09-20
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine whether results of the computed tomography coronary angiography may be helpful in planning and performing percutaneous angioplasty in patients with stable angina pectoris.

Detailed description: Currently most percutaneous coronary interventions (PCI) are planned and performed on the basis of invasive coronary angiography which provides the information that is confined to the vessel lumen. This limitation may be partially responsible for the unfavorable long term outcome and complications that occur in some patients. Additional information on the disease burden in angiographically normal coronary segments adjacent to the lesion site could impact the treatment strategy and clinical results. Imaging modalities that allow not only lumen but also vessel wall assessment include both invasive (e.g. intravascular ultrasounds - IVUS) and non-invasive (e.g. multislice computed tomography - MSCT) methods. IVUS guidance of the coronary interventions is expensive and given its invasiveness is related to the additional risk. The number of patients who are referred for coronary angiography with significant stenosis diagnosed with MSCT is rapidly increasing. Most interventional cardiologists are not familiar with coronary vessel images produced by MSCT. The aim of our study is to assess if the analyses of MSCT images before the PCI may impact the treatment strategy and immediate results. The study will enroll subjects with significant coronary stenosis diagnosed with MSCT who are referred to the catheterisation laboratory for invasive angiography and PCI. The study participants will be randomized into two groups:

Group 1 - the results of MSCT are analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation) Group 2 - interventional cardiologist is blinded to the images obtained by MSCT. The PCI procedure is performed solely on the basis of invasive coronary angiography In both study groups IVUS will be performed before and after stent implantation. The operator will be blinded to the results of pre-PCI IVUS. The second IVUS will be performed when angiographic results are optimal in the opinion of the operator. The results of the second IVUS examination will be the efficacy measure of the two compared treatment strategies.

Eligibility criteria: Inclusion Criteria:

* Stable coronary artery disease
* Planned stent implantation into single lesion in native coronary artery
* Planned stent diameter: 2.5-4.0 mm

Exclusion Criteria:

* Women younger than 50 years
* Lesion location in left main coronary artery
* Atrial fibrilation or other significant arrythmia
* Severe chronic obturatory pulmonary disease
* Hyperthyroidism
* Known allergy to contrast media
* Glomerular filtration rate \< 30
* Treatment of bifurcation lesion
* Stent implantation for in-stent restenosis

Primary outcomes:
measure: Minimal in stent lumen area as assessed by IVUS
timeFrame: Up to 10 minutes after stent implantation
measure: Adequacy of lesion coverage defined as minimal lumen area in reference segments adjacent to stent shoulder.
timeFrame: Up to 10 minutes after stent implantation
Secondary outcomes:
measure: Mean stent lumen area
timeFrame: Up to 10 minutes after stent implantation
measure: Mean lumen area and plaque and media area in 10mm segments adjucent to stent edges.
timeFrame: Up to 10 minutes after stent implantation
measure: Qualitative and quantitative assessment of potential complications (tissue prolaps, plaque shift, stent edge dissection and stent malapossition)
timeFrame: Up to 10 minutes after stent implantation
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Jerzy Pregowski, MD
role: PRINCIPAL_INVESTIGATOR
References: