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

Primary Purpose

Coronary Artery Disease, NSTEMI - Non-ST Segment Elevation MI, Fractional Flow Reserve, Myocardial

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ischemia driven revascularization
Usual care group
Sponsored by
Zuyderland Medisch Centrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brno University HospitalRecruiting
  • Gottsegen György Országos Kardiológiai IntézetRecruiting
  • Bacs-Kiskun Teaching HospitalRecruiting
  • Szeged UniversityRecruiting
  • Jeroen Bosch ZiekenhuisRecruiting
  • Zuyderland MCRecruiting
  • Maastricht University Medical CentreRecruiting
  • Viecuri Medisch CentrumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ischemia driven revascularization

Usual care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The incidence of MACE at 12 months
MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.

Secondary Outcome Measures

The incidence of MACE in subgroups at 12 and 24 months.
Prespecified subgroup analyses of primary outcomes will be performed for: Diabetic patients versus non-diabetic patients Elderly (≥ 75 years) versus young patients (< 75 years) Male versus Female gender High versus low risk patients according to GRACE Risk Score 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.
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.
Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months.
All-cause mortality or Myocardial infarction at 12, 24 and 36 months.
Any revascularisation at 12, 24 and 36 months.
Stent thrombosis at 12, 24 and 36 months.
Bleeding (major and minor) at 48 hours and 12 months.
The incidence of MACE at 36 months as well as outcomes of each component of MACE at 12 and 24 and 36 months.
MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.
Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography).

Full Information

First Posted
May 23, 2018
Last Updated
February 3, 2023
Sponsor
Zuyderland Medisch Centrum
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, Brno University Hospital, Szeged University
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1. Study Identification

Unique Protocol Identification Number
NCT03562572
Brief Title
FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease
Acronym
SLIM
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2018 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zuyderland Medisch Centrum
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, Brno University Hospital, Szeged University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, NSTEMI - Non-ST Segment Elevation MI, Fractional Flow Reserve, Myocardial, Myocardial Revascularization, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
476 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ischemia driven revascularization
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ischemia driven revascularization
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual care group
Intervention Description
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 Measure Information:
Title
The incidence of MACE at 12 months
Description
MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The incidence of MACE in subgroups at 12 and 24 months.
Description
Prespecified subgroup analyses of primary outcomes will be performed for: Diabetic patients versus non-diabetic patients Elderly (≥ 75 years) versus young patients (< 75 years) Male versus Female gender High versus low risk patients according to GRACE Risk Score 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.
Time Frame
12 and 24 months
Title
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
Title
Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months.
Time Frame
12, 24 and 36 months
Title
All-cause mortality or Myocardial infarction at 12, 24 and 36 months.
Time Frame
12, 24 and 36 months
Title
Any revascularisation at 12, 24 and 36 months.
Time Frame
12, 24 and 36 months
Title
Stent thrombosis at 12, 24 and 36 months.
Time Frame
12, 24 and 36 months
Title
Bleeding (major and minor) at 48 hours and 12 months.
Time Frame
48 hours and 12 months
Title
The incidence of MACE at 36 months as well as outcomes of each component of MACE at 12 and 24 and 36 months.
Description
MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.
Time Frame
12, 24 and 36 months
Title
Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography).
Time Frame
12, 24 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Pustjens, Drs.
Phone
+31884597777
Email
t.pustjens@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Saman Rasoul, Dr.
Phone
+31884597777
Email
s.rasoul@zuyderland.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saman Rasoul, Dr.
Organizational Affiliation
Zuyderland MC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnoud van 't Hof, Prof. Dr.
Organizational Affiliation
Zuyderland MC
Official's Role
Study Director
Facility Information:
Facility Name
Brno University Hospital
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P Kala, Prof dr
Facility Name
Gottsegen György Országos Kardiológiai Intézet
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Z. Piroth, Dr.
Facility Name
Bacs-Kiskun Teaching Hospital
City
Kecskemét
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B Berta, Dr.
Facility Name
Szeged University
City
Szeged
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoltan Ruzsa, Dr.
Facility Name
Jeroen Bosch Ziekenhuis
City
Den Bosch
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Polad, Dr.
Facility Name
Zuyderland MC
City
Heerlen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S. Rasoul, MD, PhD
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Vainer, Drs
Facility Name
Viecuri Medisch Centrum
City
Venlo
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W. Remkes, Drs.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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