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Multi Vessel Coronary Artery DiseaseNCT04252703

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

A study testing Percutaneous coronary intervention (PCI) in people with Multi Vessel Coronary Artery Disease and Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 80 years and older
What is being tested?
Percutaneous coronary intervention (PCI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteDenmark
Study dates
13 May 2020to 1 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Cardiology, Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

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

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.

Being tested
Percutaneous coronary intervention (PCI)
Keywords
ischemic heart disease, multivessel, octogenarians, acute coronary syndrome
Medical subject headings
Myocardial Ischemia, Acute Coronary Syndrome, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary intervention (PCI)Procedure or surgery

    Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.

Study groups in NCT04252703
Study groupRoleWhat they receive
MinimalistActive comparatorThe '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.
Receives: Procedure: Percutaneous coronary intervention (PCI)
More completeExperimentalThe '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.
Receives: Procedure: Percutaneous coronary intervention (PCI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Components of composite endpoint as defined below.

    Measured: 12 months

Secondary outcomes (8)

  1. Incidence of Cardiac death

    defined as death due to suspected cardiac cause (myocardial infarction, low-output heart failure or fatal arrhythmia

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. Incidence of Urgent unplanned revascularization

    (of the coronary arteries by either PCI or coronary bypass surgery)

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. Incidence of Stroke

    Defined as a clinically apparent neurological event lasting ≥24 hours verified by cerebral computed tomography (CT) or magnetic resonance imaging (MRI)

    Measured: 12 months

  6. 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)

    Measured: 72 hours after PCI

  7. Seattle Angina Questionnaire score

    Performed at study entry and at 12 months follow-up

    Measured: 12 months

  8. EQ-5D-5L quality of life assessment

    Performed at study entry and at 12 months follow-up

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start13 May 2020
  3. Primary completion1 Jan 2022
  4. Study completion1 Jan 2022

Why it stopped: Very slow recruitment - only 3 patients randomised and then COVID-19

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04252703
Sponsor's protocol ID
H-18020388
Status last verified
Jul 2024
First submitted
27 Jan 2020
Last updated
11 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous coronary intervention (PCI) in people with Multi Vessel Coronary Artery Disease and Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Very slow recruitment - only 3 patients randomised and then COVID-19). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04252703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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