Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543641
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Evaluation of Long Coronary Artery Stents With Third-generation Dual-source Computed Tomography Angiography
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Long Coronary Artery Stents With Third-generation Dual-source Computed Tomography Angiography
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to assess third-generation dual-source coronary computed tomography angiography CCTA performance in the evaluation of long coronary stents in patients with coronary artery chronic total occlusions The main questions it aims to answer are
Can patency of long coronary artery stents be assessed with third generation CCTA
What are the factors affecting the assessability
What is the radiation exposure of third generation CCTA
Can patency of long coronary artery stents be assessed with third generation CCTA
What are the factors affecting the assessability
What is the radiation exposure of third generation CCTA
Detailed Description:
This prospective study complied with the Declaration of Helsinki and was approved by the ethics committee of Helsinki University Central Hospital All patients gave a written informed consent prior to the beginning of the study
Patient selection A registry that included chronic total occlusion CTO patients with stable coronary artery disease treated for CTO with percutaneous coronary angioplasty CTO PCI in Helsinki University Central Hospital starting from 2014 was used for this study The study population included consecutive prospectively recruited patients from 2014 to 2019 All patients meeting the study criteria were included in the study
Definition Segments 5 mm proximal and 5 mm distal to the stent were considered as part of the stent for in-stent restenosis ISR evaluation as proposed by the Academic Research Consortium and were included in CCTA performance analyses Long CTO stents consisted of one or more coronary artery stents with possible combination of different stent types The combined stent length was reported without possible overlap for multiple stents The diameter of the largest stent or post-dilation balloon was reported Based on previous CT studies and guidelines radiological ISR in CCTA was defined as luminal narrowing of 50 in the long CTO stent CCTA result was considered negative if ISR was ruled out and positive if ISR was detected or if the result was inconclusive Therefore two groups defined by the CCTA result were formed In patient-based analyses patients with two long CTO stents of which at least one was a CCTA positive stent were considered as CCTA positive In native coronary arteries less than 25 was considered minimal 25-49 mild 50-69 moderate and 70-99 severe stenosis and 100 as an occlusion Assessment of stenosis was based on direct visualisation The studys experienced cardiac radiologist with over 15 years of experience was blinded for symptomatic data stent type and stent quantity The target vessel of implanted coronary artery stents was provided
All patients underwent third-generation dual-source CCTA In CCTA a non-contrast calcium score using standard 120 kilovolt kV acquisition and 3 mm slice thickness was obtained Stented segments were manually subtracted from the score Second third-generation dual-source CCTA Somatom Force Siemens was performed Prospective ECG-triggering was applied regular heart rate 70min andor in the case of previous stent implantation of right coronary artery RCA to avoid motion artefacts and FLASH- mode if the heart rate was regular and 60min If the presenting heart rate was 70min metoprolol 5-15 mg was administered intravenously For patients with higher heart rates 70min prospective ECG-gating and widening of the acquisition window padding were used Sublingual nitroglycerin was administered before scanning A tube voltage of 100 kV rotation time of 025 s temporal resolution of 66 ms collimation of 2 x 192 x 06 mm and pitch of 32 were used Approximately 50 ml of contrast medium containing 350 mgml of iodine Omnipaque 350 GE Healthcare was injected intravenously at a flow rate of 5-57 mls followed by a 47 ml saline solute Axial images were reconstructed with 06 mm slice and evaluated using multiplanar reformation Bv40 kernel Advanced Modeled Iterative Reconstruction 3 ADMIRE 3 and Iterative metal artefact reduction iMAR were utilised
Clinical information and CCTA results were assessed by the interventional cardiologists and the following patients were offered invasive coronary angiography ICA
1 Patients with a positive result in a long CTO stent
2 Patients with a positive result in a non-CTO stent
3 Patients with 50 stenosis or an inconclusive finding in any native coronary artery in patients with anginal symptoms
Physiological evaluation fractional flow reserve and intravascular imaging intravascular ultrasound optical coherence tomography were performed in ICA by the decision of the interventional cardiologist Any incidental findings were evaluated separately
Radiation exposures of CCTA and ICA were reported in dose length product DLP milligraycm and dose area product DAP graycm2 respectively DLP was converted to an effective dose mSv with a conversion factor of k 0014 and DAP with a conversion factor of k 029 The effective doses were compare between patients who received both examinations
Patients symptoms were evaluated with the validated Seattle Angina Questionnaire 7 SAQ7 via a single phone interview Dyspnea was considered as an anginal symptom All patients with SAQ7 Anginal Frequency score 100 were considered asymptomatic
At the CTO PCI optimal medical therapy was prescribed to all patients
Stent- and patient-related characteristics examined in the study
Age years body mass index kgm2 sex smoking history medical conditions at CTO PCI diabetes insulin required diabetes heart failure peripheral artery disease dyslipidemia hypertension pulmonary disease chronic kidney disease atrial fibrillation cardiac pacemaker prior myocardial infarction prior stroke prior PCI prior CABG double-CTO two treated CTOs in one procedure coronary artery dominance RCA left circumflex coronary artery LCX balanced a non-CTO stent implanted in the CTO PCI procedure clinical presentation stable angina pectoris or acute coronary syndrome CCTA Agatston calcium score stented vessel RCA left anterior descending artery LAD LCX Japanese-CTO score objective index of CTO procedure difficulty long CTO stent parameters number of consecutive stents total stent length mm stent length in lesions stented with a single stent mm stent length in lesions stented with multiple stents mm stent diameter mm duration of the follow-up since stent implantation years
The values are presented as medians and IQRs or n as appropriate The stent lengths are presented as medians and ranges minimum-maximum
Statistical analysis Descriptive statistics were reported with median and interquartile range IQR for continuous variables and with frequency for categorical variables The demographic variables of the CCTA-positive group were compared to the corresponding variables of the CCTA-negative group Categorical variables were analysed with Fishers exact test or Pearsons chi-square test and continuous or ordinal variables with Mann-Whitney U test The alpha level was 005 CCTA performance in evaluating the patency of CTO stents was analysed with sensitivity specificity negative predictive value NPV and positive predictive value PPV in patients receiving both CCTA and ICA ICA was the reference standard All the statistical analyses were performed using SPSS version 28 IBM
Patient selection A registry that included chronic total occlusion CTO patients with stable coronary artery disease treated for CTO with percutaneous coronary angioplasty CTO PCI in Helsinki University Central Hospital starting from 2014 was used for this study The study population included consecutive prospectively recruited patients from 2014 to 2019 All patients meeting the study criteria were included in the study
Definition Segments 5 mm proximal and 5 mm distal to the stent were considered as part of the stent for in-stent restenosis ISR evaluation as proposed by the Academic Research Consortium and were included in CCTA performance analyses Long CTO stents consisted of one or more coronary artery stents with possible combination of different stent types The combined stent length was reported without possible overlap for multiple stents The diameter of the largest stent or post-dilation balloon was reported Based on previous CT studies and guidelines radiological ISR in CCTA was defined as luminal narrowing of 50 in the long CTO stent CCTA result was considered negative if ISR was ruled out and positive if ISR was detected or if the result was inconclusive Therefore two groups defined by the CCTA result were formed In patient-based analyses patients with two long CTO stents of which at least one was a CCTA positive stent were considered as CCTA positive In native coronary arteries less than 25 was considered minimal 25-49 mild 50-69 moderate and 70-99 severe stenosis and 100 as an occlusion Assessment of stenosis was based on direct visualisation The studys experienced cardiac radiologist with over 15 years of experience was blinded for symptomatic data stent type and stent quantity The target vessel of implanted coronary artery stents was provided
All patients underwent third-generation dual-source CCTA In CCTA a non-contrast calcium score using standard 120 kilovolt kV acquisition and 3 mm slice thickness was obtained Stented segments were manually subtracted from the score Second third-generation dual-source CCTA Somatom Force Siemens was performed Prospective ECG-triggering was applied regular heart rate 70min andor in the case of previous stent implantation of right coronary artery RCA to avoid motion artefacts and FLASH- mode if the heart rate was regular and 60min If the presenting heart rate was 70min metoprolol 5-15 mg was administered intravenously For patients with higher heart rates 70min prospective ECG-gating and widening of the acquisition window padding were used Sublingual nitroglycerin was administered before scanning A tube voltage of 100 kV rotation time of 025 s temporal resolution of 66 ms collimation of 2 x 192 x 06 mm and pitch of 32 were used Approximately 50 ml of contrast medium containing 350 mgml of iodine Omnipaque 350 GE Healthcare was injected intravenously at a flow rate of 5-57 mls followed by a 47 ml saline solute Axial images were reconstructed with 06 mm slice and evaluated using multiplanar reformation Bv40 kernel Advanced Modeled Iterative Reconstruction 3 ADMIRE 3 and Iterative metal artefact reduction iMAR were utilised
Clinical information and CCTA results were assessed by the interventional cardiologists and the following patients were offered invasive coronary angiography ICA
1 Patients with a positive result in a long CTO stent
2 Patients with a positive result in a non-CTO stent
3 Patients with 50 stenosis or an inconclusive finding in any native coronary artery in patients with anginal symptoms
Physiological evaluation fractional flow reserve and intravascular imaging intravascular ultrasound optical coherence tomography were performed in ICA by the decision of the interventional cardiologist Any incidental findings were evaluated separately
Radiation exposures of CCTA and ICA were reported in dose length product DLP milligraycm and dose area product DAP graycm2 respectively DLP was converted to an effective dose mSv with a conversion factor of k 0014 and DAP with a conversion factor of k 029 The effective doses were compare between patients who received both examinations
Patients symptoms were evaluated with the validated Seattle Angina Questionnaire 7 SAQ7 via a single phone interview Dyspnea was considered as an anginal symptom All patients with SAQ7 Anginal Frequency score 100 were considered asymptomatic
At the CTO PCI optimal medical therapy was prescribed to all patients
Stent- and patient-related characteristics examined in the study
Age years body mass index kgm2 sex smoking history medical conditions at CTO PCI diabetes insulin required diabetes heart failure peripheral artery disease dyslipidemia hypertension pulmonary disease chronic kidney disease atrial fibrillation cardiac pacemaker prior myocardial infarction prior stroke prior PCI prior CABG double-CTO two treated CTOs in one procedure coronary artery dominance RCA left circumflex coronary artery LCX balanced a non-CTO stent implanted in the CTO PCI procedure clinical presentation stable angina pectoris or acute coronary syndrome CCTA Agatston calcium score stented vessel RCA left anterior descending artery LAD LCX Japanese-CTO score objective index of CTO procedure difficulty long CTO stent parameters number of consecutive stents total stent length mm stent length in lesions stented with a single stent mm stent length in lesions stented with multiple stents mm stent diameter mm duration of the follow-up since stent implantation years
The values are presented as medians and IQRs or n as appropriate The stent lengths are presented as medians and ranges minimum-maximum
Statistical analysis Descriptive statistics were reported with median and interquartile range IQR for continuous variables and with frequency for categorical variables The demographic variables of the CCTA-positive group were compared to the corresponding variables of the CCTA-negative group Categorical variables were analysed with Fishers exact test or Pearsons chi-square test and continuous or ordinal variables with Mann-Whitney U test The alpha level was 005 CCTA performance in evaluating the patency of CTO stents was analysed with sensitivity specificity negative predictive value NPV and positive predictive value PPV in patients receiving both CCTA and ICA ICA was the reference standard All the statistical analyses were performed using SPSS version 28 IBM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None