Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04491513
Other study ID # Amsterdam UMC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date July 1, 2020

Study information

Verified date July 2020
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: Computed tomography angiography (CTA) is already used in the work-up for transcatheter aortic valve implantation (TAVI) and could partially replace invasive coronary angiography (CAG) to rule out proximal coronary lesions.

Objectives: To assess the diagnostic accuracy and yield of pre-TAVI CTA to detect coronary lesions (≥50% DS and ≥70% DS) in the proximal coronary segments on a per-patient and a per-segment level.

Methods: The DEPICT CTA database consists of individual patient data of four studies that analysed the diagnostic accuracy of pre-TAVI CTA to detect coronary lesions. For this analysis, diagnostic accuracy was assessed in the left main and the three proximal coronary segments.


Description:

Methods Objectives To assess the diagnostic accuracy and yield of pre-TAVI CTA to detect coronary lesions (≥50% DS and ≥70% DS) in the proximal coronary segments on a per-patient and a per-segment level. The secondary objective was to perform a subgroup analysis of the individual included studies and to assess the influence of atrial fibrillation and heart rate on the diagnostic accuracy.

Literature search and study selection Studies were selected from our previous systematic review and meta-analysis on the diagnostic accuracy of CTA for the detection of significant CAD in TAVI work-up [4]. These studies were supplemented with studies that were retrieved by an updated literature search in OVID MEDLINE (including Epub Ahead of Print, In-Process & Other Non-Indexed Citations) and OVID EMBASE from January 1, 1946 to October 01, 2019. Studies were excluded if they were not reporting original data of patients who received both pre-procedural multi-detector computed tomography (MDCT) and CAG for the evaluation of CAD in the work-up of TAVI. The authors of 8 studies were approached to jointly perform a meta-analysis of individual patient data. The authors of 4 studies could accommodate the data for a per segment analysis [5-8]. The methodological quality of the included studies was assessed using the modified Quality Assessment of Studies of Diagnostic Accuracy Included in Systematic Reviews-2 criteria (QUADAS-2) [9].

Data collection The data sets included patient characteristics regarding age, sex, body mass index (BMI) and the heart rate during CT-scan. Information about co-morbidities included the presence of diabetes mellitus, atrial fibrillation, hypercholesterolemia, peripheral atrial disease, hypertension, a history of smoking, presence of CAD and a history of PCI or coronary artery bypass grafting. Technical CT scanner information included scanner type, number of detector rows, number of slices, detector width, CT scanner rotation time, scan protocol and settings (tube voltage and tube current), contrast agent type and volume, dose length product, and nitroglycerine use.

The coronary segments were categorized in three categories: lesions <50% DS, lesion ≥50-70% DS or lesions ≥70% DS), according to the 18-segment coronary model of the Society of Cardiovascular Computed Tomography or the American Heart Association modified 15-segment model [10,11]. All studies used a cut-off of ≥50% diameter stenosis to determine the presence of obstructive CAD. Three out of four studies also used a cut-off value of ≥70% DS [5,7,8], which were used for an additional analysis of the diagnostic accuracy to detect ≥70% DS proximal obstructive coronary lesions. If a segment had poor image quality or severe motion artefacts, it was labelled as non-diagnostic.

Statistical analysis Data analysis was performed using the statistical software R version 3.5.1 (R Foundation for Statistical Computing, Vienna, Austria). Continuous variables were presented as means with standard deviations (SD). The distribution of continuous variables was tested with the Shapiro-Wilk test. Categorical variables were presented as frequencies and percentages. The prevalence of proximal lesions of ≥50% DS and of ≥70% DS was computed from the measurements with invasive CAG, because revascularization with PCI is only considered in case of a proximal ≥70% DS lesion.(ref ESC guideline) Diagnostic accuracy of pre-TAVI CTA, as compared to pre-TAVI CAG, was defined as the sensitivity, specificity, positive - (PPV) and negative predictive value (NPV) and was derived from the number of true positives (TP), true negatives (TN), false positives (TP) and false negatives (FN). The analysis of the primary endpoint was performed on a per-patient and per-segment level. Diagnostic accuracy was computed for CTA to detect obstructive proximal coronary lesions of more than 50% DS and also of ≥70% DS lesions in a subgroup of patients were the data was available. All non-diagnostic segments were considered as abnormal tests and were labelled as if there was a lesion. For the per-patient analysis of diagnostic accuracy, patients were regarded as having proximal obstructive lesions if there was a minimum of one non-diagnostic segment. Diagnostic yield was defined as the number of patients that would not need an invasive CAG if pre-TAVI CTA was used as a gatekeeper to rule out obstructive proximal lesions and was derived from the sum of the negatives (TN + FN). For the subgroup analysis, we analysed the diagnostic accuracy in the individual included studies and assessed the diagnostic accuracy in the subgroups with atrial fibrillation and a heart rate <70 and ≥70 b/min. The diagnostic accuracy in the individual studies and the subgroups was assessed on a per-patient level for lesions ≥50% DS.


Recruitment information / eligibility

Status Completed
Enrollment 1060
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients in the work-up for TAVI

Exclusion Criteria:

- inability to undergo CTA

Study Design


Intervention

Diagnostic Test:
Computed tomography angiography
Computed tomography angiography for the detection of proximal coronary lesions in patients in the work-up for TAVI

Locations

Country Name City State
Netherlands Amsterdam UMC Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

Andreini D, Pontone G, Mushtaq S, Bartorelli AL, Ballerini G, Bertella E, Segurini C, Conte E, Annoni A, Baggiano A, Formenti A, Fusini L, Tamborini G, Alamanni F, Fiorentini C, Pepi M. Diagnostic accuracy of multidetector computed tomography coronary angiography in 325 consecutive patients referred for transcatheter aortic valve replacement. Am Heart J. 2014 Sep;168(3):332-9. doi: 10.1016/j.ahj.2014.04.022. Epub 2014 Jun 9. — View Citation

Hamdan A, Wellnhofer E, Konen E, Kelle S, Goitein O, Andrada B, Raanani E, Segev A, Barbash I, Klempfner R, Goldenberg I, Guetta V. Coronary CT angiography for the detection of coronary artery stenosis in patients referred for transcatheter aortic valve replacement. J Cardiovasc Comput Tomogr. 2015 Jan-Feb;9(1):31-41. doi: 10.1016/j.jcct.2014.11.008. Epub 2014 Dec 3. — View Citation

Opolski MP, Kim WK, Liebetrau C, Walther C, Blumenstein J, Gaede L, Kempfert J, Van Linden A, Walther T, Hamm CW, Möllmann H. Diagnostic accuracy of computed tomography angiography for the detection of coronary artery disease in patients referred for transcatheter aortic valve implantation. Clin Res Cardiol. 2015 Jun;104(6):471-80. doi: 10.1007/s00392-014-0806-z. Epub 2015 Jan 6. — View Citation

Rossi A, De Cecco CN, Kennon SRO, Zou L, Meinel FG, Toscano W, Segreto S, Achenbach S, Hausleiter J, Schoepf UJ, Pugliese F. CT angiography to evaluate coronary artery disease and revascularization requirement before trans-catheter aortic valve replacement. J Cardiovasc Comput Tomogr. 2017 Sep - Oct;11(5):338-346. doi: 10.1016/j.jcct.2017.06.001. Epub 2017 Jun 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy and yield of pre-TAVI CTA to detect coronary lesions (=50% DS and =70% DS) in the proximal coronary segments on a per-patient and a per-segment level. 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A