Non-ST-segment Acute Coronary SyndromeIMPACT-NSTEACSNCT03641898
Intravascular Ultrasound-derived Assessment of Hemodynamically Negative Lesions in NSTEACS Patients
An observational study of Non-ST-segment Acute Coronary Syndrome, run by Tianjin Chest Hospital at 1 site in China.
Trial summary
This is an observational and prospective cohort study to examine whether the addition of IVUS plaque morphological evaluation to FFR haemodynamic assessment of non-culprit lesions in NSTEACS patients will better predict MACEs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-ST-segment Acute Coronary Syndrome
- What is being tested?
- FFR-guided PCI and Intravascular ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2018to Oct 2025
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For study enrollment, we screen patients with NSTEACS combination of unstable angina and non-ST-segment elevation myocardial infarction according to current guidelines. Once all clinical inclusion criteria and no clinical exclusion criteria are met, patients must sign the informed consent and undergo invasive coronary angiography (ICA). During ICA patients will be further analyzed for eligibility using angiographic inclusion and exclusion criteria. Patients will be enrolled into the study once the IVUS measurement is delivered after successful FFR-guided PCI.
Clinical Inclusion Criteria:
- Moderate to high risk NSTEACS requiring invasive strategy based on current guidelines and local clinical practice.
- Patient agrees and is able to follow all protocol procedures.
Clinical Exclusion Criteria:
- STEMI or SCAD.
- Hemodynamic instability (e.g. cardiogenic shock, refractory ventricular arrhythmias, acute and severe conduction system disease and left ventricular ejection fraction ≤30%).
- Contraindication for FFR, PCI, IVUS and OMT (e.g. severe allergy to antiplatelet drug or contrast, significant bleed within the past 6 months, bleeding diathesis and serum creatinine ≥2.5 mg/dl).
- PCI within 6 months or any prior CABG.
- Anticipated life expectancy <3 year.
- Pregnancy
- Unwilling or unable to provide informed consent
Imaging Inclusion Criteria
- Patients must have at least > 1 de novo lesion in a native coronary segment with a visually estimated diameter stenosis of between 40 and 90 %.
- Successful FFR-guided PCI performed in all major epicardial coronary arteries (including their branches): PCI for all lesions a) with 40%-90% diameter stenosis and FFR<0.8 and b) with ≥90% diameter stenosis.
- The FFR-negative lesions must be available for assessment of IVUS.
Imaging Exclusion Criteria:
- Target lesion reference diameter <2.0 mm.
- Anatomic conditions precluding FFR and IVUS (e.g. marked calcification or tortuosity, chronic total occlusion or thrombus).
- After successful FFR-guided PCI, no FNL is left.
- Any remaining lesion with diameter stenosis ≥90% or FFR<0.8 after PCI.
- Left main coronary artery lesion.
- CABG planned by the investigators according to extent and severity of coronary artery disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300000
Jia Zhou, MD, 86-15522485560, zhoujiawenzhang@126.com
About this study
Official title: Intravascular Ultrasound-derived Morphometric Assessment of Fractional Flow Reserve Negative Lesions to Predict Cardiovascular Outcomes in Non-ST-segment Acute Coronary Syndrome Patients
This is an observational and prospective cohort study to examine whether the addition of IVUS plaque morphological evaluation to FFR haemodynamic assessment of non-culprit lesions in NSTEACS patients will better predict MACEs.
Read the detailed description
IMPACT-NSTEACS is a prospective, single-centre and dynamic observational study. The study population consists of NSTEACS patients who undergo FFR in lesions with intermediate to severe angiographic stenosis. Then, FFR-guided PCI is performed, followed by morphological assessment based on IVUS in all FFR-negative lesions (FNLs). After discharge all patients receive optimal medication treatment and are followed up clinically. On the basis of follow-up angiography, MACEs are further adjudicated as occurring at FNLs or not.
- Conditions
- Non-ST-segment Acute Coronary Syndrome
- Being tested
- FFR-guided PCI, Intravascular ultrasound
- Keywords
- Fractional flow reserve, Intravascular ultrasound, Major adverse cardiovascular events, Non-ST-segment acute coronary syndrome, Percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR-guided PCIProcedure or surgery
Also called Functionally complete revascularization
After the angiographic screening for lesions with 40%-90% diameter stenosis, FFR will be performed according to standard protocol using the s5 console and PrimeWire Prestige PLUS coronary pressure wire (Volcano Corporation, San Diego, California). FFR is calculated as the ratio of mean distal intracoronary pressure measured by the pressure wire, and the mean arterial pressure measured through the coronary guiding catheter. An FFR ≤0.8 or >90% diameter stenosis should result in a treatment decision for revascularization by PCI and lesions with FFR >0.80 are defined as FNLs and should result in deferral of PCI.
Intravascular ultrasoundDiagnostic test
After the successful FFR-guided PCI, IVUS will be performed in all FNLs with the ultrasound Imaging Catheter Atlantis™ SR Pro (40 MHz, mechanical-type transducer, 3.2 F, Boston Scientific Corporation, Natick, MA, USA). Quantitative analyses of grayscale IVUS include contouring external elastic membrane (EEM) and luminal borders and the measurement of EEM cross-sectional area (CSA), luminal CSA, plaque and media CSA, plaque burdenand remodeling index. Virtual assessment of plaque is performed with iMap software (QIvus 2.0; Medis Medical Imaging Systems, Leiden, The Netherlands). Plaque components are categorized as dense calcium, necrotic core, fibrofatty, and fibrous tissue and reported as absolute area and proportion of total plaque area.
| Study group | Role | What they receive |
|---|---|---|
| Morphometric assessment of FNLs | After FFR-guided PCI, the morphometric characteristics of FNLs (FFR>0.8) are assessment by intravascular ultrasound. Receives: Procedure: FFR-guided PCI; Diagnostic Test: Intravascular ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and predictors of MACEs related to FNLs
Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
Measured: 3 years
Secondary outcomes (1)
The incidence of MACEs related to PCI-treated lesions
Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start20 Oct 2018
- Primary completionOct 2023 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST-segment Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Zhang, Tianjin Chest Hospital
- Investigators
- Ying Zhang, MD, Study chair, Tianjin Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641898
- Sponsor's protocol ID
- 16KG132
- Acronym
- IMPACT-NSTEACS
- Status last verified
- Jul 2019
- First submitted
- 18 Aug 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound-derived Morphometric Assessment of Fractional Flow Reserve Negative Lesions to Predict Cardiovascular Outcomes in Non-ST-segment Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT03641898
- Acronym / sponsor ID
- IMPACT-NSTEACS / 16KG132
- Conditions
- Non-ST-segment Acute Coronary Syndrome
- Keywords
- Fractional flow reserve, Intravascular ultrasound, Major adverse cardiovascular events, Non-ST-segment acute coronary syndrome, Percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Tianjin Chest HospitalUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 22 Aug 2018 (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.
This is an observational and prospective cohort study to examine whether the addition of IVUS plaque morphological evaluation to FFR haemodynamic assessment of non-culprit lesions in NSTEACS patients will better predict MACEs.
Detailed description
IMPACT-NSTEACS is a prospective, single-centre and dynamic observational study. The study population consists of NSTEACS patients who undergo FFR in lesions with intermediate to severe angiographic stenosis. Then, FFR-guided PCI is performed, followed by morphological assessment based on IVUS in all FFR-negative lesions (FNLs). After discharge all patients receive optimal medication treatment and are followed up clinically. On the basis of follow-up angiography, MACEs are further adjudicated as occurring at FNLs or not.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morphometric assessment of FNLs | – | Procedure: FFR-guided PCI, Diagnostic Test: Intravascular ultrasoundAfter FFR-guided PCI, the morphometric characteristics of FNLs (FFR>0.8) are assessment by intravascular ultrasound. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For study enrollment, we screen patients with NSTEACS combination of unstable angina and non-ST-segment elevation myocardial infarction according to current guidelines. Once all clinical inclusion criteria and no clinical exclusion criteria are met, patients must sign the informed consent and undergo invasive coronary angiography (ICA). During ICA patients will be further analyzed for eligibility using angiographic inclusion and exclusion criteria. Patients will be enrolled into the study once the IVUS measurement is delivered after successful FFR-guided PCI.
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 |
|---|---|---|
| FFR-guided PCIAlso: Functionally complete revascularizationAfter the angiographic screening for lesions with 40%-90% diameter stenosis, FFR will be performed according to standard protocol using the s5 console and PrimeWire Prestige PLUS coronary pressure wire (Volcano Corporation, San Diego, California). FFR is calculated as the ratio of mean distal intracoronary pressure measured by the pressure wire, and the mean arterial pressure measured through the coronary guiding catheter. An FFR ≤0.8 or >90% diameter stenosis should result in a treatment decision for revascularization by PCI and lesions with FFR >0.80 are defined as FNLs and should result in deferral of PCI. | Procedure or surgery | Morphometric assessment of FNLs |
| Intravascular ultrasoundAfter the successful FFR-guided PCI, IVUS will be performed in all FNLs with the ultrasound Imaging Catheter Atlantis™ SR Pro (40 MHz, mechanical-type transducer, 3.2 F, Boston Scientific Corporation, Natick, MA, USA). Quantitative analyses of grayscale IVUS include contouring external elastic membrane (EEM) and luminal borders and the measurement of EEM cross-sectional area (CSA), luminal CSA, plaque and media CSA, plaque burdenand remodeling index. Virtual assessment of plaque is performed with iMap software (QIvus 2.0; Medis Medical Imaging Systems, Leiden, The Netherlands). Plaque components are categorized as dense calcium, necrotic core, fibrofatty, and fibrous tissue and reported as absolute area and proportion of total plaque area. | Diagnostic test | Morphometric assessment of FNLs |
Primary outcome
The incidence and predictors of MACEs related to FNLs
Time frame: 3 years
Composite of death from cardiac causes, myocardial infarction, rehospitalization due to unstable or progressive angina and clinically-driven target lesion revascularization
1 secondary outcome
The incidence of MACEs related to PCI-treated lesions
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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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.
Ying Zhang, MD study chair
Tianjin Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-ST-segment Acute Coronary Syndrome, run by Tianjin Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 10 Jul 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Zhou, MD (86-15522485560, zhoujiawenzhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and predictors of MACEs related to FNLs (time frame: 3 years). 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 10 Jul 2019.