Saline-induced Distal to Aortic Coronary Pressure Ratio vs. Resting and Hyperemic Indices of Coronary Artery Stenosis Severity (SALINE)
Primary Purpose
Coronary Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Saline Pd/Pa
Sponsored by
About this trial
This is an interventional supportive care trial for Coronary Stenosis
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥18 years of age.
- Subject must be willing to sign a Patient Informed Consent (PIC).
- Coronary artery disease with over 50% angiographic diameter stenosis on visual assessment, undergoing clinically indicated invasive physiological assessment by means of FFR.
- Assessment of non culprit arteries with over 50% angiographic diameter stenosis on visual assessment, in patients presenting with NSTEMI.
Exclusion Criteria:
- Pregnant and/or breastfeeding females.
- Known allergies to: heparin, contrast medium, adenosine.
- Contra-indication to adenosine.
- Severe renal failure (eGFR ≤ 30 ml/min/m2).
- Ostial stenosis in both the left and right coronary arteries.
- Presence of a chronic total occlusion.
- History of coronary artery bypass graft.
- Acute coronary syndrome.
- Acute myocardial infarction within the preceding two weeks.
- Severe valvular heart disease.
- Left main disease.
- Documented left ventricular ejection fraction (LVEF) ≤30% as documented within maximum 6 months prior to the procedure.
- Decompensated congestive heart failure.
- Extreme hypotension (systolic blood pressure <100 mmHg)
- Extreme bradycardia (<40 bpm).
Sites / Locations
- Geneva University HospitalsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Saline Pd/Pa
Arm Description
Eligible subjects will undergo invasive coronary physiology measurements including whole cycle resting Pd/Pa, iFR, RFR, cFFR, Saline Pd/Pa and FFR
Outcomes
Primary Outcome Measures
Saline Pd/Pa ratio
As the patient will undergo invasive physiological assessment of an angiographic intermediate stenosis with fractional flow reserve (FFR), as per ESC guidelines recommendation (class of recommendation I, level of evidence A), we will perform measurement of saline Pd/Pa with the same pressure guidewire, requiring an additional 3-5 minutes and injection of 10 ml of saline.
Contrast Fractional Flow Reserve (FFR)
As the patient will undergo invasive physiological assessment of an angiographic intermediate stenosis with fractional flow reserve (FFR), as per ESC guidelines recommendation (class of recommendation I, level of evidence A), we will perform measurement of contrast fractional flow reserve (FFR) with the same pressure guidewire, requiring an additional 3-5 minutes and injection of 10 ml of contrast.
Adenosine Fractional Flow Reserve (FFR)
The patient will undergo invasive physiological assessment of an angiographic intermediate stenosis with fractional flow reserve (FFR), as per ESC guidelines recommendation (class of recommendation I, level of evidence A).
Resting Pd/Pa ratio
As the patient will undergo invasive physiological assessment of an angiographic intermediate stenosis with fractional flow reserve (FFR), as per ESC guidelines recommendation (class of recommendation I, level of evidence A), we will perform measurement of Pd/Pa with the same pressure guidewire, requiring an additional 3-5 minutes.
Instantaneous wave-free ratio (iFR)
The patient will undergo invasive physiological assessment of an angiographic intermediate stenosis with instantaneous wave-free ratio (iFR), as per ESC guidelines recommendation (class of recommendation I, level of evidence A).
Secondary Outcome Measures
Full Information
NCT ID
NCT04284345
First Posted
January 9, 2020
Last Updated
December 4, 2022
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT04284345
Brief Title
Saline-induced Distal to Aortic Coronary Pressure Ratio vs. Resting and Hyperemic Indices of Coronary Artery Stenosis Severity
Acronym
SALINE
Official Title
Diagnostic Accuracy of the Saline-induced Distal to Aortic Coronary Pressure Ratio Compared With Clinically Available Resting and Hyperemic Indices of Coronary Artery Stenosis Severity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The presence of inducible myocardial ischemia is considered as the prerequisite for the clinical benefit of coronary revascularization. In this regard, the introduction of invasive pressure-derived physiological indices to guide myocardial revascularization represented a major breakthrough for the treatment of patients with coronary artery disease (CAD), by moving the focus of coronary revascularization from anatomy to physiology . The main premise of coronary physiology is to permit determination of the functional significance of individual stenoses on a per-vessel basis, measurable at the time of clinical decision-making process, thus providing an objective marker to identify ischemic lesions, and therefore patients, most likely to benefit from coronary revascularization .
Fractional flow reserve (FFR) is the most widely used pressure-derived invasive physiological index for coronary lesion assessment in contemporary clinical practice. FFR is calculated as the ratio of the mean distal coronary pressure (Pd) to the mean proximal coronary pressure (Pa) across a stenosis during maximal hyperaemia, a condition that is commonly achieved by the intracoronary or intravenous administration of a potent vasodilator agent, such as adenosine. Based on the results of landmark clinical trials, most recent guidelines recommend the use of FFR to identify hemodynamically significant coronary lesions in patients with stable CAD. Despite this, the worldwide adoption of FFR into current clinical practice remains limited , accounting for only 9.8% of coronary procedures in Switzerland . Potential reasons for the low adoption rate of coronary physiology include technical challenges and time consumption related to FFR measurements, inadequate or lack of reimbursement, physician preferences, patient-related discomfort, contraindications and costs associated with adenosine, or in certain countries, no availability of adenosine.
The low use of FFR in clinical practice provided a rationale for the development of new invasive physiology indices. By negating the need for administration of pharmacologic agents such as adenosine, saving time, and reducing costs and side effects, hyperaemia-free pressure-derived physiological indices were developed to increase adoption of physiology-guided coronary revascularization into routine clinical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
560 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Saline Pd/Pa
Arm Type
Experimental
Arm Description
Eligible subjects will undergo invasive coronary physiology measurements including whole cycle resting Pd/Pa, iFR, RFR, cFFR, Saline Pd/Pa and FFR
Intervention Type
Procedure
Intervention Name(s)
Saline Pd/Pa
Intervention Description
Use of a ≥6F guiding catheter and the Verrata pressure guidewire. Administration of intracoronary nitroglycerin.
Verrata normalisation and placement of the Verrata sensor ≥3 vessel-diameter beyond the stenosis.
Whole cycle resting Pd/Pa and resting iFR measurements.
Measurement of contrast FFR: record 5 baseline heart beats, injection of contrast media, 10 ml in the left coronary system, 8 ml in the right coronary system, measure minimal Pd/Pa under stable hyperaemia.
Adenosine FFR: measurement: record 5 baseline heart beats, injection of intracoronary adenosine, 200 mcg in the left coronary system, 100 mcg in the right coronary system, measure minimal Pd/Pa under stable hyperaemia.
Saline-induced Pd/Pa measurement: record 5 baseline heart beats, injection of saline using the ACIST system during 5 heart beats, measure minimal Pd/Pa under stable hyperaemia.
Perform pressure guidewire pullback and check for drift: drift ±0.02 is accepted, if ≥0.03, repeat measurement.
Primary Outcome Measure Information:
Title
Saline Pd/Pa ratio
Description
As the patient will undergo invasive physiological assessment of an angiographic intermediate stenosis with fractional flow reserve (FFR), as per ESC guidelines recommendation (class of recommendation I, level of evidence A), we will perform measurement of saline Pd/Pa with the same pressure guidewire, requiring an additional 3-5 minutes and injection of 10 ml of saline.
Time Frame
during the coronarography procedure
Title
Contrast Fractional Flow Reserve (FFR)
Description
As the patient will undergo invasive physiological assessment of an angiographic intermediate stenosis with fractional flow reserve (FFR), as per ESC guidelines recommendation (class of recommendation I, level of evidence A), we will perform measurement of contrast fractional flow reserve (FFR) with the same pressure guidewire, requiring an additional 3-5 minutes and injection of 10 ml of contrast.
Time Frame
during the coronarography procedure
Title
Adenosine Fractional Flow Reserve (FFR)
Description
The patient will undergo invasive physiological assessment of an angiographic intermediate stenosis with fractional flow reserve (FFR), as per ESC guidelines recommendation (class of recommendation I, level of evidence A).
Time Frame
during the coronarography procedure
Title
Resting Pd/Pa ratio
Description
As the patient will undergo invasive physiological assessment of an angiographic intermediate stenosis with fractional flow reserve (FFR), as per ESC guidelines recommendation (class of recommendation I, level of evidence A), we will perform measurement of Pd/Pa with the same pressure guidewire, requiring an additional 3-5 minutes.
Time Frame
during the coronarography procedure
Title
Instantaneous wave-free ratio (iFR)
Description
The patient will undergo invasive physiological assessment of an angiographic intermediate stenosis with instantaneous wave-free ratio (iFR), as per ESC guidelines recommendation (class of recommendation I, level of evidence A).
Time Frame
during the coronarography procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is ≥18 years of age.
Subject must be willing to sign a Patient Informed Consent (PIC).
Coronary artery disease with over 50% angiographic diameter stenosis on visual assessment, undergoing clinically indicated invasive physiological assessment by means of FFR.
Assessment of non culprit arteries with over 50% angiographic diameter stenosis on visual assessment, in patients presenting with NSTEMI.
Exclusion Criteria:
Pregnant and/or breastfeeding females.
Known allergies to: heparin, contrast medium, adenosine.
Contra-indication to adenosine.
Severe renal failure (eGFR ≤ 30 ml/min/m2).
Ostial stenosis in both the left and right coronary arteries.
Presence of a chronic total occlusion.
History of coronary artery bypass graft.
Acute coronary syndrome.
Acute myocardial infarction within the preceding two weeks.
Severe valvular heart disease.
Left main disease.
Documented left ventricular ejection fraction (LVEF) ≤30% as documented within maximum 6 months prior to the procedure.
Decompensated congestive heart failure.
Extreme hypotension (systolic blood pressure <100 mmHg)
Extreme bradycardia (<40 bpm).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan F Iglesias, MD
Phone
+41 79 553 34 67
Email
JuanFernando.Iglesias@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Degrauwe, MD
Phone
+41 79 553 02 94
Email
Sophie.Degrauwe@hcuge.ch
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Degrauwe, MD
Phone
+41 79 553 02 94
Email
Sophie.Degrauwe@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Juan F Iglesias, MD
Phone
+41 79 553 34 67
Email
JuanFernando.Iglesias@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Sophie Degrauwe, MD
First Name & Middle Initial & Last Name & Degree
Juan F Iglesias, MD
12. IPD Sharing Statement
Learn more about this trial
Saline-induced Distal to Aortic Coronary Pressure Ratio vs. Resting and Hyperemic Indices of Coronary Artery Stenosis Severity
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