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Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (PRIMULTI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Odense University Hospital
Aalborg Universitetshospital
Aarhus University Hospital
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01960933
First received: October 9, 2013
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.


Condition Intervention
ST-elevation Myocardial Infarction.
Multi Vessel Disease.
Procedure: Percutaneous coronary intervention
Procedure: FFR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • All cause death, myocardial infarction or revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure


Secondary Outcome Measures:
  • Cardiac death or myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Hospitalization for acute coronary syndrome or acute heart failure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Angina status and quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Infarct size in relation to area at risk as determined by MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Wall motion index (WMI) determined by echocardiography [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: May 2011
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Culprit lesion revascularization
Only the culprit lesion is treated whereas other study lesions are left un-treated.
Procedure: Percutaneous coronary intervention
Active Comparator: Full revascularization
Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically >50% and FFR <0.80 are treated in a separate procedure within the index hospitalization. Stenoses > 90% are treated without prior FFR.
Procedure: Percutaneous coronary intervention Procedure: FFR

Detailed Description:

STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR).

Eligible coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses > 50% can be randomized. All randomized lesions with diameter stenosis > 50% and < 90% are evaluated by FFR and a FFR value < 0.80 is considered significant and treated. Stenoses >90% are treated without prior FFR.

Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Acute onset of chest pain of < 12 hours' duration.
  • ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
  • Culprit lesion in a major native vessel.
  • MVD (non-culprit vessels with angiographic stenosis >50%)
  • Successful primary PCI

Exclusion Criteria:

  • Pregnancy.
  • Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast.
  • Inability to understand information or to provide informed consent.
  • Haemorrhagic diathesis or known coagulopathy.
  • Stent thrombosis
  • Significant left main stem stenosis
  • Cardiogenic shock at admittance
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960933

Locations
Denmark
Aalborg University Hospital
Aalborg, Denmark, 9100
Skejby University Hospital
Aarhus, Denmark, 8200
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, 2100
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Rigshospitalet, Denmark
Odense University Hospital
Aalborg Universitetshospital
Aarhus University Hospital
Investigators
Study Chair: Steffen Helqvist, MD, DMSci Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator: Thomas Engstrøm, MD, DMSci Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator: Henning Kelbæk, MD. DMSci Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator: Lars Køber, MD, Prof., DMSci Rigshospitalet, University of Copenhagen, Denmark
  More Information

No publications provided

Responsible Party: Thomas Engstrom, MD, Senior Consultant, DMSCi, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01960933     History of Changes
Other Study ID Numbers: DANAMI-3-PRIMULTI
Study First Received: October 9, 2013
Last Updated: August 28, 2014
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
STEMI
MVD
Full revascularization
Culprit lesion revascularization only
Primary PCI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014