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

ST-elevation Myocardial Infarction Clinical Trial

— PRIMULTI  

Official title:

Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01960933
• Other study ID #: DANAMI-3-PRIMULTI
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infarction
• Multi Vessel Disease
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-elevation Myocardial Infarction

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