Cardiac IschemiaiStrategyNCT05006183
Instantaneous Wave-free Ratio Guidance Strategy Evaluation in the Treatment of Multivessel Acute Coronary Syndrome.
A study testing PCI in people with Cardiac Ischemia and Acute Coronary Syndrome, run by Daugavpils Regional Hospital at 1 site in Latvia.
Trial summary
A single-center, prospective, randomized, open-label, blinded end-point clinical trial of instantaneous wave-free ratio (iFR) guidance strategy impact on clinical outcomes in multivessel acute coronary syndrome (ACS) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Ischemia, Acute Coronary Syndrome
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLatvia
- Study dates
- 8 Aug 2019to Sep 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
- 18 years of age and older
- willing to give informed consent
- hemodynamically stable de novo acute coronary syndrome patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries
- adequate coronary flow, Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2
- sinus rhythm
Who cannot join
- inability to give consent;
- younger than 18 years of age
- atrial fibrillation rhythm at the time of inclusion
- with significant valve disease
- in cardiogenic shock
- with reduced kidney function - eGFR < 30 (mL/min/1.73m2);
Show all 11Show fewer
- with congenital heart defects
- with acute pulmonary artery embolism;
- with isolated left main ostial stenosis;
- on active oncologic treatment or toxic cardiomyopathy;
- revascularization by PCI is not possible due to other comorbidities or patient denial of treatment.
Trial locations and contacts
1 site in 1 country.
Latvia1 site, 1 recruiting
- Recruiting
Daugavpils Regional Hospital
Daugavpils, LV-5417
Deniss Vasiljevs, MD, +37165440858, d.vasiljevs@siadrs.lv
About this study
Official title: Characterization of Coronary Artery Hemodynamic Measurements and Virtual Angioplasty Planning by Instantaneous Wave-free Ratio (iFR) in Multivessel Acute Coronary Syndrome Patients With Evaluation of the Impact on Clinical Outcomes.
A single-center, prospective, randomized, open-label, blinded end-point clinical trial of instantaneous wave-free ratio (iFR) guidance strategy impact on clinical outcomes in multivessel acute coronary syndrome (ACS) patients.
Read the detailed description
The "all-comers" study population consists of hemodynamically stable de novo ACS patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries with Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2 and willing to sign a patient informed consent. ACS diagnosis established by angina pectoris symptoms and/or ECG changes and/or hs-troponin I levels. The use of drug-eluting stents is mandatory in both treatment groups. In the intervention strategy group, patients are treated by the iFR-guided percutaneous coronary intervention (PCI) in one stage. In the control group, patients are treated in accordance with the standard practice of angiography-guided staged approach.
- Conditions
- Cardiac Ischemia, Acute Coronary Syndrome
- Being tested
- PCI
- Keywords
- iFR, Instantaneous wave free ratio, virtual percutaneous coronary intervention, Acute coronary syndrome, Multivessel
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Percutaneous coronary intervention with Drug-Eluting Stents
| Study group | Role | What they receive |
|---|---|---|
| iFR-guided | Experimental | One-stage, virtually planned, iFR-guided and optimized PCI. Receives: Procedure: PCI |
| Angiography-guided | Active comparator | Standard practice staged angiography-guided PCI Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCI-related Major adverse cardiac events (MACE)
Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation.
Measured: Index admission
PCI-related Major adverse cardiac events (MACE)
Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation.
Measured: 3 months
PCI-related Major adverse cardiac events (MACE)
Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation.
Measured: 12 months
Secondary outcomes (3)
Segmental myocardial deformation by speckle-tracking echocardiography
Change of segmental myocardial deformation
Measured: Index admission, 3 months and 12 months
Health-related Quality of Life
Change in health-related quality of life measured using the EQ-5D-5L questionnaire
Measured: Index admission, 3 months and 12 months
Number of Participants with Decline of eGFR
Number of participants with decline of eGFR 30% and more in comparison to the first eGFR
Measured: Index admission, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start8 Aug 2019
- Primary completionAug 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac IschemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daugavpils Regional Hospital
- Sponsor type
- Other government
- Collaborators
- Riga Stradins University
- Responsible party
- Principal investigator, Deniss Vasiljevs, Daugavpils Regional Hospital
- Investigators
- Deniss Vasiljevs, MD, Principal investigator, Daugavpils Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006183
- Sponsor's protocol ID
- SP0001
- Acronym
- iStrategy
- Status last verified
- Apr 2022
- First submitted
- 2 Aug 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Coronary Artery Hemodynamic Measurements and Virtual Angioplasty Planning by Instantaneous Wave-free Ratio (iFR) in Multivessel Acute Coronary Syndrome Patients With Evaluation of the Impact on Clinical Outcomes.
- ClinicalTrials.gov ID
- NCT05006183
- Acronym / sponsor ID
- iStrategy / SP0001
- Conditions
- Cardiac Ischemia, Acute Coronary Syndrome
- Keywords
- iFR, Instantaneous wave free ratio, virtual percutaneous coronary intervention, Acute coronary syndrome, Multivessel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Daugavpils Regional HospitalOther government
- Collaborators
- Riga Stradins University
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 16 Aug 2021 (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.
A single-center, prospective, randomized, open-label, blinded end-point clinical trial of instantaneous wave-free ratio (iFR) guidance strategy impact on clinical outcomes in multivessel acute coronary syndrome (ACS) patients.
Detailed description
The "all-comers" study population consists of hemodynamically stable de novo ACS patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries with Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2 and willing to sign a patient informed consent. ACS diagnosis established by angina pectoris symptoms and/or ECG changes and/or hs-troponin I levels. The use of drug-eluting stents is mandatory in both treatment groups. In the intervention strategy group, patients are treated by the iFR-guided percutaneous coronary intervention (PCI) in one stage. In the control group, patients are treated in accordance with the standard practice of angiography-guided staged approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iFR-guided | Experimental | Procedure: PCIOne-stage, virtually planned, iFR-guided and optimized PCI. |
| Angiography-guided | Active comparator | Procedure: PCIStandard practice staged angiography-guided PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older
- willing to give informed consent
- hemodynamically stable de novo acute coronary syndrome patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries
- adequate coronary flow, Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2
- sinus rhythm
Key exclusion criteria (11 listed)
- inability to give consent;
- younger than 18 years of age
- atrial fibrillation rhythm at the time of inclusion
- with significant valve disease
- in cardiogenic shock
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 |
|---|---|---|
| PCIPercutaneous coronary intervention with Drug-Eluting Stents | Procedure or surgery | Angiography-guided, iFR-guided |
Primary outcome
PCI-related Major adverse cardiac events (MACE)
Time frame: Index admission
Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation.
PCI-related Major adverse cardiac events (MACE)
Time frame: 3 months
Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation.
PCI-related Major adverse cardiac events (MACE)
Time frame: 12 months
Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation.
3 secondary outcomes
Segmental myocardial deformation by speckle-tracking echocardiography
Time frame: Index admission, 3 months and 12 months
Health-related Quality of Life
Time frame: Index admission, 3 months and 12 months
Number of Participants with Decline of eGFR
Time frame: Index admission, 3 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Cardiac Ischemia
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
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.
Deniss Vasiljevs, MD principal investigator
Daugavpils Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI in people with Cardiac Ischemia and Acute Coronary Syndrome, run by Daugavpils Regional Hospital at 1 site in Latvia.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 29 Apr 2022. 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 Latvia. 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 Deniss Vasiljevs, MD (+37165440858, d.vasiljevs@siadrs.lv), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCI-related Major adverse cardiac events (MACE) (time frame: Index admission). The study lists 3 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 29 Apr 2022.