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NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation (IMPACTavi)

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ClinicalTrials.gov Identifier: NCT04976062
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : July 26, 2021
Sponsor:
Collaborator:
Infraredx Inc
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief Summary:
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Aortic Stenosis, Severe Diagnostic Test: Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation; the IMPACTavi Trial
Actual Study Start Date : November 10, 2020
Estimated Primary Completion Date : May 10, 2024
Estimated Study Completion Date : May 10, 2024



Intervention Details:
  • Diagnostic Test: Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)
    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.


Primary Outcome Measures :
  1. Incidence of major adverse cardiac events as assessed during clinical follow-up and according to current VARC-definitions [ Time Frame: 24 months ]
    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


Secondary Outcome Measures :
  1. Freedom from NIRS-IVUS-emergent complications as assessed by post-NIRS-IVUS control angiography [ Time Frame: 3 months ]
    NIRS-IVUS-emergent complications are defined as coronary impairment following performance of NIRS-IVUS imaging

  2. Incidence of acute kidney injury as assessed during clinical follow-up and according to RIFLE/AKIN-criteria [ Time Frame: 3 months ]
  3. Incidence of major vascular complications as assessed during clinical follow-up and according to current VARC-defintions [ Time Frame: 3 months ]
  4. Incidence of major- or life-threatening bleedings as assessed during clinical follow-up and according to current VARC-definitions [ Time Frame: 3 months ]
  5. Incidence of any stroke as assessed during clinical follow-up and according to current VARC-definitions [ Time Frame: 3 months ]
  6. Incidence of all-cause mortality as assessed during clinical follow-up [ Time Frame: 24-months ]
  7. Incidence of myocardial infarction as assessed during clinical follow-up according to current VARC-definitions [ Time Frame: 24 months ]
  8. Incidence of unplanned coronary revascularization as assessed during clinical follow-up [ Time Frame: 24 months ]
  9. Incidence of hospital readmission as assessed during clinical follow-up [ Time Frame: 24 months ]
  10. Incidence of any coronary revascularization as assessed during clinical follow-up [ Time Frame: 24 months ]
  11. Incidence of hospital readmission due to angina pectoris or equivalent as assessed during clinical follow-up [ Time Frame: 24 months ]
  12. NYHA class as defined by the New York Heart Association Functional Classification assessed at 24-months clinical follow-up [ Time Frame: 24 months ]
  13. CCS class as defined by the Canadian Cardiovascular Society grading of angina pectoris assessed at 24-months clinical follow-up [ Time Frame: 24 months ]
  14. Delta left-ventricular ejection fraction at 3- and 12-months follow-up compared to baseline [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe aortic stenosis referred for TAVI with concomitant coronary artery disease
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years and able to give consent
  2. Severe aortic stenosis found eligible for transfemoral TAVI by the multi-disciplinary heart team
  3. Angiographic evidence of coronary artery disease with absence of coronary stents in at least one native coronary artery
  4. At least 30 mm of total NIRS-IVUS pullback length in sufficient quality for offline analysis of at least one native coronary artery with absence of coronary stents, containing at least one lesion requiring NIRS-IVUS imaging for clinical indications
  5. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
  6. In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

  1. Age < 18years
  2. Any clinical contraindications to perform NIRS-IVUS
  3. ST-elevation myocardial infarction or cardiogenic shock within 48h prior to enrollment
  4. Decompensated aortic valve stenosis requiring emergency TAVI
  5. History of coronary artery bypass graft (CABG)
  6. Severe renal failure with estimated glomerular filtration rate <20 ml/min
  7. Malignancies or other comorbid conditions (resulting in a life expectancy <12 months)
  8. Inability to fully cooperate with the study protocol
  9. Known allergy towards P2Y12 receptor antagonists
  10. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04976062


Locations
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Germany
Deutsches Herzzentrum München Recruiting
Munich, Bavaria, Germany, 80636
Contact: Michael Joner, MD    +49 89 12180    joner@dhm.mhn.de   
Contact: Tobias Lenz, MD    +49 89 12180    lenzt@dhm.mhn.de   
Principal Investigator: Michael Joner, MD         
Sub-Investigator: Tobias Lenz, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Infraredx Inc
Investigators
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Principal Investigator: Michael Joner, MD Deutsches Herzzentrum München
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Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT04976062    
Other Study ID Numbers: GE IDE No. T00120
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Deutsches Herzzentrum Muenchen:
Transcatheter aortic valve implantation
Near-infrared spectroscopy
Intravascular imaging
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aortic Valve Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aortic Valve Disease
Heart Valve Diseases
Ventricular Outflow Obstruction