Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

NCT ID: NCT02445885

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2039-03-01

Brief Summary

Although recommended therapy for patients with ST-segment elevation myocardial infarction is primary PCI, it remains unestablished whether patients with a symptom duration of more 12 hours benefit from acute revascularisation.

This study aims to investigate whether acute intervention is superior to subacute intervention in these patients.

Detailed Description

The recommended therapy for patients with ST-segment elevation myocardial infarction (STEMI) is to restore normal coronary blood flow with timely reperfusion by percutaneous coronary intervention (PCI), and thereby minimize the extent of cell death and preserving cardiac function. The duration of ischemia and timely PCI are major determinants for the size of the myocardial infarction and prognosis. Thus, acute PCI should be performed within 12 hours after symptom onset. The effect of PCI and timing of PCI are, however, much more uncertain for late presenters who contact the health service > 12 hours from symptom. Thus, it is still unknown whether late presenters should be treated with acute PCI or medical treatment with delayed PCI (24-72 h after first medical contact).

The study investigates the effect on final salvage index evaluated by magnetic resonance imaging of acute PCI of late presenters.

The overall objective of the study is to investigate whether late presenters may benefit from acute PCI, and thus whether to extend the currently recommended time limit of 12 hours for acute PCI in patients with STEMI.

Conditions

Ischemic Heart Disease; ST-segment Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acute PCI

Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours

Group Type: EXPERIMENTAL

PCI

Intervention Type: PROCEDURE

Guideline directed Percutaneous Coronary Intervention

Subacute PCI

Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours

Group Type: ACTIVE_COMPARATOR

PCI

Intervention Type: PROCEDURE

Guideline directed Percutaneous Coronary Intervention

Interventions

PCI

Guideline directed Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients more than 18 years of age.
• STEMI > 12 hours and < 36 hours.
• Clinical stable, i.e. no on going angina, hemodynamically stable (systolic BP > 90) and Killip class < 3.

Exclusion Criteria

• Clinical instability which requires an acute invasive strategy.
• Left main occlusion or multivessel disease which requires CABG.
• Previous Q-wave infarction in the current infarct related artery.
• Left Bundle Branch Block (LBBB).
• Severe renal insufficiency.
• Pacemaker
• Chronic atrial fibrillation.
• Previous Coronary Artery Bypass Surgery (CABG).
• Pregnancy.
• Other severe illness with life expectancy less than 1 year

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Engstrom

OTHER

Sponsor Role: lead

Responsible Party

Thomas Engstrom

Chief Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lars Nepper-Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Lars Nepper-Christensen, MD

Role: CONTACT

lars.nepper@gmail.com

+4535457586

Thomas Engstrøm, MDSci, PhD

Role: CONTACT

thomas.engstroem@regionh.dk

+4535452017

Facility Contacts

Lars Nepper-Christensen, MD

Role: primary

Thomas Engstrøm, DSci, PhD

Role: backup

References

Terkelsen CJ, Sorensen JT, Maeng M, Jensen LO, Tilsted HH, Trautner S, Vach W, Johnsen SP, Thuesen L, Lassen JF. System delay and mortality among patients with STEMI treated with primary percutaneous coronary intervention. JAMA. 2010 Aug 18;304(7):763-71. doi: 10.1001/jama.2010.1139.

Reference Type: BACKGROUND

PMID: 20716739 (View on PubMed)

Carlsson M, Ubachs JF, Hedstrom E, Heiberg E, Jovinge S, Arheden H. Myocardium at risk after acute infarction in humans on cardiac magnetic resonance: quantitative assessment during follow-up and validation with single-photon emission computed tomography. JACC Cardiovasc Imaging. 2009 May;2(5):569-76. doi: 10.1016/j.jcmg.2008.11.018.

Reference Type: BACKGROUND

PMID: 19442942 (View on PubMed)

Busk M, Kaltoft A, Nielsen SS, Bottcher M, Rehling M, Thuesen L, Botker HE, Lassen JF, Christiansen EH, Krusell LR, Andersen HR, Nielsen TT, Kristensen SD. Infarct size and myocardial salvage after primary angioplasty in patients presenting with symptoms for <12 h vs. 12-72 h. Eur Heart J. 2009 Jun;30(11):1322-30. doi: 10.1093/eurheartj/ehp113. Epub 2009 Apr 8.

Reference Type: RESULT

PMID: 19357105 (View on PubMed)

Schomig A, Mehilli J, Antoniucci D, Ndrepepa G, Markwardt C, Di Pede F, Nekolla SG, Schlotterbeck K, Schuhlen H, Pache J, Seyfarth M, Martinoff S, Benzer W, Schmitt C, Dirschinger J, Schwaiger M, Kastrati A; Beyond 12 hours Reperfusion AlternatiVe Evaluation (BRAVE-2) Trial Investigators. Mechanical reperfusion in patients with acute myocardial infarction presenting more than 12 hours from symptom onset: a randomized controlled trial. JAMA. 2005 Jun 15;293(23):2865-72. doi: 10.1001/jama.293.23.2865.

Reference Type: RESULT

PMID: 15956631 (View on PubMed)

Other Identifiers

LATE-MI

Identifier Type: -

Identifier Source: org_study_id