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FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease (SLIM)

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ClinicalTrials.gov Identifier: NCT03562572
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : July 14, 2021
Sponsor:
Collaborators:
Maastricht University Medical Center
Radboud University Medical Center
Jeroen Bosch Ziekenhuis
VieCuri Medical Centre
Gottsegen György Országos Kardiológiai Intézet
Bács-Kiskun County Teaching Hospital
Information provided by (Responsible Party):
Saman Rasoul, Zuyderland Medisch Centrum

Brief Summary:
To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease NSTEMI - Non-ST Segment Elevation MI Fractional Flow Reserve, Myocardial Myocardial Revascularization Percutaneous Coronary Intervention Procedure: Ischemia driven revascularization Other: Usual care group Not Applicable

Detailed Description:

Background:

Patients with non-ST elevation myocardial infarction (non-STEMI), as compared with STEMI patients, have a higher risk profile, more often MVD and less favourable outcome. Recent studies showed that complete revascularization in STEMI patients is feasible and effective. However, there is no clear evidence regarding the role of complete coronary revascularization by PCI in patients with non-STEMI with MVD.

Objective:

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

Design:

Prospective, multicentre, 1:1 randomized, investigator initiated study.

Hypothesis:

FFR guided complete percutaneous revascularisation of all significant stenosis in the non-culprit lesion performed within the index PCI procedure will improve clinical outcomes compared to the usual care, guided by discretion of the physician.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It concerns an investigator initiated prospective 1:1 randomised clinical trial in non-STEMI patients with multivessel coronary artery disease amenable to treatment with PCI.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ischemia (FFR) Driven Complete Revascularization Versus Usual Care in Patients With Non-ST Elevation Myocardial Infarction and Multivessel Diseases: The South Limburg Myocardial Infarction Study Group The SLIM Study
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Ischemia driven revascularization
In the ischemia driven complete revascularisation strategy group all flow limiting (FFR ≤ 0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload, which may lead to deterioration of cardiac and renal function of the patient.
Procedure: Ischemia driven revascularization
In the ischemia driven complete revascularisation strategy group all flow limiting (FFR ≤ 0.80) lesions will receive treatment by PCI and stenting during the index intervention

Active Comparator: Usual care group
In the randomised to usual care group the procedure will stop after the PCI of the culprit artery and the patient will be referred to his treating cardiologist and/ or heart team who will decide whether a staged PCI of the non- IRA artery should take place. If the treating cardiologist (after advise of the heart team) decides to perform the non-IRA PCI revascularisation, than such treatment should take place within six weeks from the primary PCI in order to count as a scheduled staged PCI procedure.
Other: Usual care group
In the randomised to usual care group the procedure will stop after the PCI of the culprit artery and the patient will be referred to his treating cardiologist and/ or heart team who will decide whether a staged PCI of the non- IRA artery should take place. If the treating cardiologist (after advise of the heart team) decides to perform the non-IRA PCI revascularisation, than such treatment should take place within six weeks from the primary PCI in order to count as a scheduled staged PCI procedure.




Primary Outcome Measures :
  1. The incidence of MACE at 12 months [ Time Frame: 12 months ]
    MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.


Secondary Outcome Measures :
  1. The incidence of MACE in subgroups at 12 and 24 months. [ Time Frame: 12 and 24 months ]

    Prespecified subgroup analyses of primary outcomes will be performed for:

    1. Diabetic patients versus non-diabetic patients
    2. Elderly (≥ 75 years) versus young patients (< 75 years)
    3. Male versus Female gender
    4. High versus low risk patients according to GRACE Risk Score
    5. Patients previous myocardial infarction versus patients with no previous myocardial infarction

    The Global Registry of Acute Coronary Events (GRACE) score estimates the admission 6 month mortality for patients with acute coronary syndrome. The GRACE score ranges from 0 to > 285. A higher GRACE represents a higher mortality risk, ranging from 0-2% when the GRACE is between 0 and 87, to 99% when the GRACE exceeds 285.


  2. Composite endpoint of Net Adverse Clinical Events (NACE) defined as composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and major bleeding at 12, 24 and 36 months. [ Time Frame: 12, 24 and 36 months ]
  3. Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months. [ Time Frame: 12, 24 and 36 months ]
  4. All-cause mortality or Myocardial infarction at 12, 24 and 36 months. [ Time Frame: 12, 24 and 36 months ]
  5. Any revascularisation at 12, 24 and 36 months. [ Time Frame: 12, 24 and 36 months ]
  6. Stent thrombosis at 12, 24 and 36 months. [ Time Frame: 12, 24 and 36 months ]
  7. Bleeding (major and minor) at 48 hours and 12 months. [ Time Frame: 48 hours and 12 months ]
  8. The incidence of MACE at 36 months as well as outcomes of each component of MACE at 12 and 24 and 36 months. [ Time Frame: 12, 24 and 36 months ]
    MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.

  9. Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography). [ Time Frame: 12, 24 and 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 18-85 years presenting with non-STEMI according to current guidelines, who will be treated with PCI of the culprit and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.
  • Non-IRA stenosis amenable for PCI treatment (operator's decision)
  • Signed informed consent

Exclusion Criteria:

  • Left main disease (stenosis > 50%)
  • Chronic total occlusion of a non-IRA
  • Indication for or previous coronary artery bypass grafting
  • Uncertain culprit lesion
  • Complicated IRA treatment, e.g. extravasation, permanent no re-flow after IRA treatment (TIMI flow 0-1) and inability to implant a stent
  • Known severe cardiac valve dysfunction that will require surgery or TAVI in the follow-up period.
  • Killip class III or IV during the completion of culprit lesion treatment.
  • Life expectancy of < 1 year.
  • Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor or Heparin.
  • Gastrointestinal or genitourinary bleeding within the prior 3 months.
  • Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  • Pregnancy

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): NCT03562572


Contacts
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Contact: Tobias Pustjens, Drs. +31884597777 t.pustjens@gmail.com
Contact: Saman Rasoul, Dr. +31884597777 s.rasoul@zuyderland.nl

Locations
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Hungary
Gottsegen György Országos Kardiológiai Intézet Recruiting
Budapest, Hungary
Contact: Z. Piroth, Dr.         
Bacs-Kiskun Teaching Hospital Recruiting
Kecskemét, Hungary
Contact: B Berta, Dr.         
Szeged University Recruiting
Szeged, Hungary
Contact: Zoltan Ruzsa, Dr.         
Netherlands
Jeroen Bosch Ziekenhuis Recruiting
Den Bosch, Netherlands
Contact: J. Polad, Dr.         
Zuyderland MC Recruiting
Heerlen, Netherlands
Contact: S. Rasoul, MD, PhD         
Maastricht University Medical Centre Recruiting
Maastricht, Netherlands
Contact: J. Vainer, Drs         
Viecuri Medisch Centrum Recruiting
Venlo, Netherlands
Contact: W. Remkes, Drs.         
Sponsors and Collaborators
Zuyderland Medisch Centrum
Maastricht University Medical Center
Radboud University Medical Center
Jeroen Bosch Ziekenhuis
VieCuri Medical Centre
Gottsegen György Országos Kardiológiai Intézet
Bács-Kiskun County Teaching Hospital
Investigators
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Principal Investigator: Saman Rasoul, Dr. Zuyderland MC
Study Director: Arnoud van 't Hof, Prof. Dr. Zuyderland MC
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Responsible Party: Saman Rasoul, Principal Investigator, Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier: NCT03562572    
Other Study ID Numbers: 17-T-142
28708 ( Other Identifier: NTR )
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Non-ST Elevated Myocardial Infarction
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis