Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252703
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Francis Joshi, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Multi Vessel Coronary Artery Disease Ischemic Heart Disease Acute Coronary Syndrome Heart Diseases Cardiovascular Diseases Arteriosclerosis Procedure: Percutaneous coronary intervention (PCI) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians Presenting With Non-ST-elevation Acute Coronary Syndromes: The MIMOSA Trial
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2024

Arm Intervention/treatment
Active Comparator: Minimalist
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.
Procedure: Percutaneous coronary intervention (PCI)
Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.

Experimental: More complete
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.
Procedure: Percutaneous coronary intervention (PCI)
Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.




Primary Outcome Measures :
  1. Incidence of a composite endpoint of all-cause death, recurrent myocardial infarction, urgent unplanned revascularization, TIMI major bleeding and/or stroke at 12 months. [ Time Frame: 12 months ]
    Components of composite endpoint as defined below.


Secondary Outcome Measures :
  1. Incidence of Cardiac death [ Time Frame: 12 months ]
    defined as death due to suspected cardiac cause (myocardial infarction, low-output heart failure or fatal arrhythmia

  2. Incidence of Myocardial infarction [ Time Frame: 12 months ]
    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

  3. Incidence of Urgent unplanned revascularization [ Time Frame: 12 months ]
    (of the coronary arteries by either PCI or coronary bypass surgery)

  4. Incidence of TIMI major and minor bleeding [ Time Frame: 12 months ]
    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.

  5. Incidence of Stroke [ Time Frame: 12 months ]
    Defined as a clinically apparent neurological event lasting ≥24 hours verified by cerebral computed tomography (CT) or magnetic resonance imaging (MRI)

  6. Incidence of contrast-induced nephropathy after PCI [ Time Frame: 72 hours 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)

  7. Seattle Angina Questionnaire score [ Time Frame: 12 months ]
    Performed at study entry and at 12 months follow-up

  8. EQ-5D-5L quality of life assessment [ Time Frame: 12 months ]
    Performed at study entry and at 12 months follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04252703


Contacts
Layout table for location contacts
Contact: Francis Joshi, MD,PhD +4535452905 francis.richard.joshi@regionh.dk
Contact: Hanna Ratcovich, MD +4535454007 hanna.louise.ratcovich.01@regionh.dk

Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Thomas Engstrøm, MD, PhD Rigshospitalet, Denmark
Principal Investigator: Francis Joshi, MD,PhD Rigshospitalet, Denmark
Layout table for additonal information
Responsible Party: Francis Joshi, Principal Investigator, Interventional Cardiologist, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04252703    
Other Study ID Numbers: H-18020388
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francis Joshi, Rigshospitalet, Denmark:
ischemic heart disease
multivessel
octogenarians
acute coronary syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Acute Coronary Syndrome
Arteriosclerosis
Syndrome
Cardiovascular Diseases
Disease
Pathologic Processes
Coronary Disease
Arterial Occlusive Diseases
Vascular Diseases