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

Cardiovascular Diseases Clinical Trial

Official title:

'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians Presenting With Non-ST-elevation Acute Coronary Syndromes: The MIMOSA Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04252703
• Other study ID #: H-18020388
• Status: Terminated
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Multi Vessel Coronary Artery Disease
• Myocardial Ischemia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Incidence of Cardiac death	defined as death due to suspected cardiac cause (myocardial infarction, low-output heart failure or fatal arrhythmia	12 months
Secondary	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	12 months
Secondary	Incidence of Urgent unplanned revascularization	(of the coronary arteries by either PCI or coronary bypass surgery)	12 months
Secondary	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.	12 months
Secondary	Incidence of Stroke	Defined as a clinically apparent neurological event lasting =24 hours verified by cerebral computed tomography (CT) or magnetic resonance imaging (MRI)	12 months
Secondary	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)	72 hours after PCI
Secondary	Seattle Angina Questionnaire score	Performed at study entry and at 12 months follow-up	12 months
Secondary	EQ-5D-5L quality of life assessment	Performed at study entry and at 12 months follow-up	12 months