Coronary StenosisSALINENCT04284345
Saline-induced Distal to Aortic Coronary Pressure Ratio vs. Resting and Hyperemic Indices of Coronary Artery Stenosis Severity
A study testing Saline Pd/Pa in people with Coronary Stenosis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- Saline Pd/Pa
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Jan 2020to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Coronary Stenosis
- Being tested
- Saline Pd/Pa
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Pd/PaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Saline Pd/Pa | Experimental | Eligible subjects will undergo invasive coronary physiology measurements including whole cycle resting Pd/Pa, iFR, RFR, cFFR, Saline Pd/Pa and FFR Receives: Procedure: Saline Pd/Pa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the coronarography procedure
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.
Measured: during the coronarography procedure
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).
Measured: during the coronarography procedure
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.
Measured: during the coronarography procedure
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).
Measured: during the coronarography procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start31 Jan 2020
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IGLESIAS Juan Fernando, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284345
- Sponsor's protocol ID
- 2019-00910
- Other IDs
- 2019
- Acronym
- SALINE
- Status last verified
- May 2024
- First submitted
- 9 Jan 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04284345
- Acronym / sponsor ID
- SALINE / 2019-00910
- Conditions
- Coronary Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saline Pd/Pa | Experimental | Procedure: Saline Pd/PaEligible subjects will undergo invasive coronary physiology measurements including whole cycle resting Pd/Pa, iFR, RFR, cFFR, Saline Pd/Pa and FFR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline Pd/PaUse 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. | Procedure or surgery | Saline Pd/Pa |
Primary outcome
Saline Pd/Pa ratio
Time frame: during the coronarography procedure
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)
Time frame: during the coronarography procedure
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)
Time frame: during the coronarography procedure
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
Time frame: during the coronarography procedure
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)
Time frame: during the coronarography procedure
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Pd/Pa in people with Coronary Stenosis, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saline Pd/Pa ratio (time frame: during the coronarography procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.