An observational study in Coronary Artery Disease and Aortic Stenosis, Severe, sponsored by Deutsches Herzzentrum Muenchen. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by Deutsches Herzzentrum Muenchen · Observational
The aim of the IMPACTavi prospective cohort study is to test feasibility and safety of clinically indicated intravascular coronary imaging with NIRS-IVUS in addition to routine coronary angiography in patients scheduled for TAVI, to improve assessment of CAD severity in this challenging group of patients.
Concomitant coronary artery disease (CAD) is frequent in patients referred for transcatheter aortic valve replacement (TAVI) and there is evidence for a subsequent prognostic impairment. Percutaneous coronary intervention (PCI) is believed to improve prognosis in selected cases, which is why current guidelines recommend PCI to be considered in case of coronary artery diameter stenosis > 70% in proximal segments. Beyond those cases, selection is hampered by inherent shortcoming of the assessment of CAD severity by angiography alone as well as clinical and complex hemodynamic interactions between both pathologies. In patients with CAD alone, the FDA-cleared near-infrared spectroscopy and intravascular imaging (NIRS-IVUS) dual imaging catheter (Indfraredx, Inc., Bedford, USA) has proven the ability to reliably measure lipid plaque burden as well as to identify patients and plaques at increased risk for future adverse cardiovascular events. NIRS-IVUS imaging offers the unique possibility to improve angiographic CAD severity assessment in patients referred for TAVI, avoiding the influence of hemodynamic interactions and pathophysiological overlap between CAD and severe AS.
The IMPACTavi trial is designed as a prospective, non-randomized cohort study to investigate whether NIRS-IVUS-derived lesion characteristics will allow identification of patients likely to suffer adverse clinical events during clinical follow-up after TAVI. Patients with severe aortic stenosis will be qualified for enrollment if routine coronary angiography during diagnostic workup before TAVI shows evidence of coronary artery disease with at least one native vessel without prior stent implantation and at least one lesion requiring NIRS-IVUS imaging for clinical indications, and if at 30mm of total NIRS-IVUS pullback length in sufficient quality for offline analysis have been obtained. Clinical indication, technique and timing of PCI and TAVI will be at the discretion of the interdisciplinary heart-team. The primary and secondary endpoints will be assessed during clinical follow-up out to 24 months. Findings from NIRS-IVUS imaging will be analyzed on a patient- and lesion-level, in order to evaluate correlations of high- vs. low-risk lesion characteristics to the incidence of patient- and lesion-level MACE.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 150 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
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Patients with severe aortic stenosis referred for TAVI with concomitant coronary artery disease
Exclusion Criteria:
The NIRS-IVUS technique is an intravascular imaging technique, combining morphological information derived from intravascular ultrasound (IVUS) and molecular information on plaque composition, namely its respective lipid-core burden, using spectral differences between cholesterol and collagen, detected by near-infrared spectroscopy (NIRS). A combined NIRS-IVUS pullback results in a color-coded map indicating the probability of lipid-rich plaque presence in yellow, co-registered to the corresponding IVUS cross-sections.
Incidence of major adverse cardiac events as assessed during clinical follow-up and according to current VARC-definitions
Major adverse cardiac events (MACE) is defined as the composite of all-cause mortality, myocardial infarction, unplanned coronary revascularization and hospital readmission due to acute coronary syndrome
Time frame: 24 months
Freedom from NIRS-IVUS-emergent complications as assessed by post-NIRS-IVUS control angiography during initial hospital stay, on average 5 days
NIRS-IVUS-emergent complications are defined as coronary impairment following performance of NIRS-IVUS imaging
Time frame: initial hospital stay
Incidence of acute kidney injury according to RIFLE/AKIN-criteria assessed during initial hospital stay, on average 5 days
Time frame: initial hospital stay
Incidence of major vascular complications according to current VARC-defintions, assessed during initial hospital stay, on average 5 days
Time frame: initial hospital stay
Incidence of major- or life-threatening bleedings according to current VARC-definitions, assessed during initial hospital stay, on average 5 days
Time frame: initial hospital stay
Incidence of any stroke according to current VARC-definitions, assessed during initial hospital stay, on average 5 days
Time frame: initial hospital stay
Incidence of all-cause mortality as assessed during clinical follow-up
Time frame: 24-months
Incidence of myocardial infarction as assessed during clinical follow-up according to current VARC-definitions
Time frame: 24 months
Incidence of unplanned coronary revascularization as assessed during clinical follow-up
Time frame: 24 months
Incidence of hospital readmission as assessed during clinical follow-up
Time frame: 24 months
Incidence of any coronary revascularization as assessed during clinical follow-up
Time frame: 24 months
Incidence of hospital readmission due to angina pectoris or equivalent as assessed during clinical follow-up
Time frame: 24 months
NYHA class as defined by the New York Heart Association Functional Classification assessed at 24-months clinical follow-up
Time frame: 24 months
CCS class as defined by the Canadian Cardiovascular Society grading of angina pectoris assessed at 24-months clinical follow-up
Time frame: 24 months
Delta left-ventricular ejection fraction at 3- and 12-months follow-up compared to baseline
Time frame: 24 months
Plan to share: Undecided
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Deutsches Herzzentrum Muenchen