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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01960933
Other study ID # DANAMI-3-PRIMULTI
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 2011
Est. completion date February 2024

Study information

Verified date November 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 650
Est. completion date February 2024
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Percutaneous coronary intervention

FFR


Locations

Country Name City State
Denmark Aalborg University Hospital Aalborg
Denmark Rigshospitalet, University of Copenhagen Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary All cause death, myocardial infarction or revascularization 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 1 year
Secondary Cardiac death or myocardial infarction 1 year
Secondary Hospitalization for acute coronary syndrome or acute heart failure 1 year
Secondary Angina status and quality of life 1 year
Secondary Infarct size in relation to area at risk as determined by MRI 3 months
Secondary Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions 2 years
Secondary Wall motion index (WMI) determined by echocardiography 1 year
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