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Trial record 5 of 1177 for:    adenosine

Adenosine Contrast CorrELations in Evaluating RevAscularizaTION (ACCELERATION)

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ClinicalTrials.gov Identifier: NCT03557385
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
Acist Medical Systems
Information provided by (Responsible Party):
Duke University

Brief Summary:

The purpose of this study is to compare FFR measurements done with adenosine to FFR measurements done with contrast, where the contrast is injected using the ACIST CVi automated contrast injector.

The ACCELERATION study will support a safer approach to FFR for patients by potentially reducing toxic drug exposure (adenosine). The 2 main objectives of the study are:

  1. Perform a methods comparison between cFFR and the reference standard aFFR, where cFFR is performed using an automated injector with a standardized volume and rate of delivery of contrast with known osmolality.
  2. Evaluate the association between final post-PCI FFR and long-term clinical outcomes. The long-term clinical outcomes will include TVR and composite MACE (death, MI, and TVR) at 30 days and 1 year.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Drug: Iopamidol Drug: adenosine Device: Navvus® Catheter Device: CVi® Contrast Delivery System Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
aFFR vs cFFR
All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System
Drug: Iopamidol

aFFR measurement with drug: Iopamidol (ISOVUE®-370). Subjects will receive an injector-based intracoronary bolus of contrast

  • Rate of 4 mL/sec, volume of 10 cc (left coronary system)
  • Rate of 3 mL/sec, volume of 6 cc (right coronary system).
Other Name: Contrast Fractional Flow Reserve Measurement

Drug: adenosine
FFR measurement with drug: adenosine. Intravenous adenosine will be administered at a rate of 140 μg/kg of body weight per minute x 2 minutes
Other Name: Adenosine Fractional Flow Reserve Measurement

Device: Navvus® Catheter
the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing

Device: CVi® Contrast Delivery System
The CVi® Contrast Delivery System will be used to deliver the contrast medium




Primary Outcome Measures :
  1. Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) [ Time Frame: Baseline ]
    Subjects' aFFR measurement will be plotted on the x-axis, and their cFFR measurement will be plotted on the y-axis. The plot will be examined for highly influential points and heterogeneity of variance along the range of measurement values. In addition, several types of difference plots similar to the Bland-Altman plot will be used to examine whether the size of the variance changes with changing measurement value, the bias changes with changing measurement value and the coefficient of variation changes with changing measurement value. Then, the appropriate model will be applied to describe the relationship of aFFR measured values to their corresponding cFFR values

  2. Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves [ Time Frame: Baseline ]
    The qualitative method comparison assesses the agreement as to which lesion is flow limiting. If a lesion has an adenosine FFR measurement the cutoff value of 0.8, then the lesion is considered flow limiting. Using the model developed above, the contrast FFR measurement that corresponds to adenosine FFR measurement value of 0.8 will be used as the cutoff value for determining whether a lesion is flow limiting for contrast FFR.

  3. Assessment of the Relationship Between Post-Percutaneous Coronary Intervention Fractional Flow Reserves and Long-Term Clinical Outcomes [ Time Frame: 1 year ]
    assesses whether there is a relationship between final PCI FFR (resting, dPR, cFFR, aFFR) and long-term outcomes (death, MI, TVR). The model will include the known covariates for predicting revascularization outcomes: stent length, vessel diameter, diabetes, history of cardiovascular disease, and multi-vessel disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have the capacity to understand and sign an informed consent or have a legally authorized representative (LAR) that can understand and sign an informed consent prior to initial arteriotomy access
  2. Age > 18 years of age at the time of signing the informed consent
  3. Clinically stable and undergoing non-emergent cardiac catheterization for appropriate indications
  4. Willing to be contacted by telephone at 30 days (if no standard of care visit) and at 1 year with chart review for events.
  5. Target vessel with an intermediate lesion of 40-70% stenosis by angiographic assessment (a visual estimation by the operator). Serial lesions, diffuse disease, or ostial lesions ("all-comer" lesions) are acceptable if the operator would normally perform FFR and proceed with PCI (or other revascularization) if positive.

Exclusion Criteria:

  1. Any condition associated with a life expectancy of less than 1 year
  2. Participation in another clinical study using an investigational agent or device within the past 3 months
  3. Ejection fraction ≤ 35%
  4. Creatinine ≥ 2
  5. Severe valvular heart disease
  6. Decompensated acute diastolic or systolic heart failure
  7. Bronchospastic chronic obstructive pulmonary disease or other intolerance to adenosine
  8. ST-segment elevation myocardial infarction culprit lesion or lesions with any thrombus burden after diagnostic angiography
  9. Lesions with severe calcification after diagnostic angiography
  10. Lesions in a target vessel supplied by a patent graft

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): NCT03557385


Contacts
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Contact: Marjan Cobbaert, MPH 919-864-0910 mr157@duke.edu

Locations
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United States, California
Long Beach VA Recruiting
Long Beach, California, United States, 90822
Contact: Najeeb Shirwany         
United States, Minnesota
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Stephannie Knutson         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Coley Landvik         
United States, North Carolina
Durham VA Recruiting
Durham, North Carolina, United States, 27701
Contact: Kathy A         
Principal Investigator: Rajesh Swaminathan, MD         
United States, Tennessee
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37212
Contact: Terry Weyand         
Sponsors and Collaborators
Duke University
Acist Medical Systems
Investigators
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Principal Investigator: Rajesh Swaminathan, MD DCRI

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03557385     History of Changes
Other Study ID Numbers: Pro00093001
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
Fractional Flow Reserve
Additional relevant MeSH terms:
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Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action