Back to results'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians
Primary Purpose
Multi Vessel Coronary Artery Disease, Ischemic Heart Disease, Acute Coronary Syndrome
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Percutaneous coronary intervention (PCI)
Sponsored by
About this trial
This is an interventional treatment trial for Multi Vessel Coronary Artery Disease focused on measuring ischemic heart disease, multivessel, octogenarians, acute coronary syndrome
Eligibility Criteria
Inclusion Criteria:
- Age ≥80 years
Non-ST-elevation acute coronary syndromes, defined as per guidelines:
- Ischaemic chest pain or equivalent AND either
- Electrocardiography with persistent or transient ST-depression and/or T-wave inversion OR
- Biomarker positive for myocardial necrosis
- Multi-vessel coronary artery disease, defined as the presence of an angiographic >90% diameter or FFR-(<0.81) or iFR-(<0.90) positive stenoses(29) in a non-culprit vessel of reference diameter ≥2.5mm.
Exclusion Criteria:
- Inability to give written informed consent
- Resuscitation from cardiac arrest
- Life expectancy <12 months
- Cardiogenic shock
- Ventricular arrhythmias refractory to treatment at the time of randomization
- Coronary artery disease not amenable to PCI
- Heart Team decision for coronary bypass surgery
- Type 2 myocardial infarction(30) or alternative diagnoses such as tako-tsubo cardiomyopathy, as defined by the operator in light of the clinical picture at presentation
- Estimated glomerular filtration rate (eGFR) <20mL/min/m2 (by Cockcroft-Gault formula)
- Documented anaphylaxis induced by iodinated contrast media
- Documented allergies to either aspirin, clopidogrel, ticagrelor or oral anticoagulants
Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, the following:
- Active internal bleeding
- Bleeding diastheses precluding treatment with dual antiplatelet therapy and/or oral anticoagulation
- Platelet count <90,000/μL at screening
- Previous intracranial haemorrhage
- Clinically significant gastrointestinal bleeding within 12 months before randomization
- Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities at screening (confirmed with repeat testing): alanine transaminase (ALT) >5 times the upper limit of normal or ALT >3 times the upper limit of normal plus total bilirubin >2 times the upper limit of normal
- Major surgery, biopsy of a parenchymal organ, or serious trauma (including head trauma) within the past 30 days
- Any active non-cutaneous malignancy
Sites / Locations
- Department of Cardiology, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Minimalist
More complete
Arm Description
The 'Minimalist' strategy is PCI treatment of the culprit lesion only. Other coronary stenoses are to be managed medically. It is recognized that there may be multiple culprit lesions in such patients, though there are no data on how frequently this might be expected. Operators may elect to treat multiple putative culprit lesions in this case.
The 'More complete' strategy is PCI of the culprit lesion and fractional flow reserve (FFR)- or instantaneous wave-free ratio (iFR)-guided treatment of other angiographically significant (> 50% diameter) stenoses amenable to coronary stenting in vessels with reference diameters ≥2.5mm. Physiological assessment is strongly encouraged but not mandatory for lesions of ≥90% angiographic stenosis. PCI of chronic total occlusions will not be attempted as part of the study.
Outcomes
Primary Outcome Measures
Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months.
Components of composite endpoint as defined below.
Secondary Outcome Measures
Incidence of Cardiac death
defined as death due to suspected cardiac cause (myocardial infarction, low-output heart failure or fatal arrhythmia
Incidence of Myocardial infarction
Periprocedural myocardial infarction is defined as a CK-MB x 5 upper limit of normal (ULN) with ECG or angiographic evidence of ischaemia, or CK-MB x 10 ULN
Incidence of Urgent unplanned revascularization
(of the coronary arteries by either PCI or coronary bypass surgery)
Incidence of TIMI major and minor bleeding
defined as any symptomatic intracranial haemorrhage or clinically overt signs of haemorrhage (including imaging) associated with a drop in haemoglobin of ≥ 5g/dL. Minor bleeding is defined as any clinically overt sign of haemorrhage (including imaging) that is associated with a fall in haemoglobin concentration of 3 to ≤5 g/dL.
Incidence of Stroke
Defined as a clinically apparent neurological event lasting ≥24 hours verified by cerebral computed tomography (CT) or magnetic resonance imaging (MRI)
Incidence of contrast-induced nephropathy after PCI
Defined as a 25% relative increase, or a 44μmol/L absolute increase in serum creatinine within 72 hours of contrast exposure in the absence of an alternative explanation)
Seattle Angina Questionnaire score
Performed at study entry and at 12 months follow-up
EQ-5D-5L quality of life assessment
Performed at study entry and at 12 months follow-up
Full Information
NCT ID
NCT04252703
First Posted
January 27, 2020
Last Updated
April 28, 2022
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04252703
Brief Title
'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians
Official Title
'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians Presenting With Non-ST-elevation Acute Coronary Syndromes: The MIMOSA Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Very slow recruitment - only 3 patients randomised
Study Start Date
May 13, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
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
Older patients with co-morbidity are increasingly represented in interventional cardiology practice. They have been historically excluded from studies regarding the optimal management of NSTEACS. Though there are associated risks with invasive treatment, such patients likely derive the greatest absolute benefit from PCI. Small, though highly selective, studies suggest a routine invasive strategy may reduce the risk of recurrent myocardial infarction.
The study aims to include, as far as possible, an 'all-comers' population of patients aged 80 and above to define the optimum amount of revascularization required to achieve good outcomes and satisfactory symptom relief for this challenging cohort of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multi Vessel Coronary Artery Disease, Ischemic Heart Disease, Acute Coronary Syndrome, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
Keywords
ischemic heart disease, multivessel, octogenarians, acute coronary syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minimalist
Arm Type
Active Comparator
Arm Description
The 'Minimalist' strategy is PCI treatment of the culprit lesion only. Other coronary stenoses are to be managed medically. It is recognized that there may be multiple culprit lesions in such patients, though there are no data on how frequently this might be expected. Operators may elect to treat multiple putative culprit lesions in this case.
Arm Title
More complete
Arm Type
Experimental
Arm Description
The 'More complete' strategy is PCI of the culprit lesion and fractional flow reserve (FFR)- or instantaneous wave-free ratio (iFR)-guided treatment of other angiographically significant (> 50% diameter) stenoses amenable to coronary stenting in vessels with reference diameters ≥2.5mm. Physiological assessment is strongly encouraged but not mandatory for lesions of ≥90% angiographic stenosis. PCI of chronic total occlusions will not be attempted as part of the study.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention (PCI)
Intervention Description
Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.
Primary Outcome Measure Information:
Title
Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months.
Description
Components of composite endpoint as defined below.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of Cardiac death
Description
defined as death due to suspected cardiac cause (myocardial infarction, low-output heart failure or fatal arrhythmia
Time Frame
12 months
Title
Incidence of Myocardial infarction
Description
Periprocedural myocardial infarction is defined as a CK-MB x 5 upper limit of normal (ULN) with ECG or angiographic evidence of ischaemia, or CK-MB x 10 ULN
Time Frame
12 months
Title
Incidence of Urgent unplanned revascularization
Description
(of the coronary arteries by either PCI or coronary bypass surgery)
Time Frame
12 months
Title
Incidence of TIMI major and minor bleeding
Description
defined as any symptomatic intracranial haemorrhage or clinically overt signs of haemorrhage (including imaging) associated with a drop in haemoglobin of ≥ 5g/dL. Minor bleeding is defined as any clinically overt sign of haemorrhage (including imaging) that is associated with a fall in haemoglobin concentration of 3 to ≤5 g/dL.
Time Frame
12 months
Title
Incidence of Stroke
Description
Defined as a clinically apparent neurological event lasting ≥24 hours verified by cerebral computed tomography (CT) or magnetic resonance imaging (MRI)
Time Frame
12 months
Title
Incidence of contrast-induced nephropathy after PCI
Description
Defined as a 25% relative increase, or a 44μmol/L absolute increase in serum creatinine within 72 hours of contrast exposure in the absence of an alternative explanation)
Time Frame
72 hours after PCI
Title
Seattle Angina Questionnaire score
Description
Performed at study entry and at 12 months follow-up
Time Frame
12 months
Title
EQ-5D-5L quality of life assessment
Description
Performed at study entry and at 12 months follow-up
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥80 years
Non-ST-elevation acute coronary syndromes, defined as per guidelines:
Ischaemic chest pain or equivalent AND either
Electrocardiography with persistent or transient ST-depression and/or T-wave inversion OR
Biomarker positive for myocardial necrosis
Multi-vessel coronary artery disease, defined as the presence of an angiographic >90% diameter or FFR-(<0.81) or iFR-(<0.90) positive stenoses(29) in a non-culprit vessel of reference diameter ≥2.5mm.
Exclusion Criteria:
Inability to give written informed consent
Resuscitation from cardiac arrest
Life expectancy <12 months
Cardiogenic shock
Ventricular arrhythmias refractory to treatment at the time of randomization
Coronary artery disease not amenable to PCI
Heart Team decision for coronary bypass surgery
Type 2 myocardial infarction(30) or alternative diagnoses such as tako-tsubo cardiomyopathy, as defined by the operator in light of the clinical picture at presentation
Estimated glomerular filtration rate (eGFR) <20mL/min/m2 (by Cockcroft-Gault formula)
Documented anaphylaxis induced by iodinated contrast media
Documented allergies to either aspirin, clopidogrel, ticagrelor or oral anticoagulants
Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, the following:
Active internal bleeding
Bleeding diastheses precluding treatment with dual antiplatelet therapy and/or oral anticoagulation
Platelet count <90,000/μL at screening
Previous intracranial haemorrhage
Clinically significant gastrointestinal bleeding within 12 months before randomization
Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities at screening (confirmed with repeat testing): alanine transaminase (ALT) >5 times the upper limit of normal or ALT >3 times the upper limit of normal plus total bilirubin >2 times the upper limit of normal
Major surgery, biopsy of a parenchymal organ, or serious trauma (including head trauma) within the past 30 days
Any active non-cutaneous malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Engstrøm, MD, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis Joshi, MD,PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians
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