Early Discharge After Primary Percutaneous Coronary Intervention

NCT ID: NCT01860079

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-05-31

Brief Summary

• When Primary percutaneous coronary intervention (PPCI) is performed expeditiously and at a high-volume centre, it is the optimal approach for ST elevation myocardial infarction (STEMI) . In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge.
• An early discharge strategy may be desired by all parties (financial health care provider, treating physician, nurse, patient, patient's relatives)involved in STEMI.
• The main goal in our study is to test the hypothesis that an early discharge strategy within 48-56 hours in patients with successful PPCI is as safe as in those patients who stay longer (96-120 hours) as of a standard procedure.

Detailed Description

• Primary percutaneous coronary intervention (PPCI) has become the optimal reperfusion strategy for ST elevation myocardial infarction (STEMI) when the procedure is performed expeditiously and at a high-volume centre.In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge.
• It is conceivable to discharge patients with successful PPCI as early as possible, because a hospital stay longer than needed may create undesirable outcomes in terms of hospital infections, psychosocial reasons, adequate mobilization and patient comfort. In many tertiary centres with a busy PPCI programme insufficient bed capacity is an ongoing concern and threatens the continuous acceptance of new cases of acute infarctions. In addition, it has been indicated that an early discharge policy may lead to a substantial cost saving.
• Although much work has been done in developing and validating risk scores that identify low risk patients, data on the implementation of early discharge strategies have been quite limited There are 3 randomised trials investigating the possibility of early discharge after PPCI. However, certain limitations of these studies are preventing to implement an early discharge strategy in all-comers, particularly because of the underrepresentation of older patients in clinical trials. The verification of this policy is also needed in patients with multivessel disease. The first prospective randomized trial, the PAMI II,7 is partly obsolete as major changes have been made in PPCI with respect to devices and adjunctive medication. The other two randomized trials were single-center pilot studies with small number of patients.
• Therefore, the above mentioned literature information warrants to test the reproducibility of safety endpoints in a large scale multicenter trial, prior to application of the early discharge strategy in clinical practice.

Conditions

ST Elevation Myocardial Infarction

Study Design

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

Study Groups

Early discharge group

In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.

Group Type: ACTIVE_COMPARATOR

early discharge

Intervention Type: PROCEDURE

In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.

Standard discharge group

Patients who stay longer (96-120 hours) as of a standard procedure

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

early discharge

In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Signed informed consent and subsequent written agreement of a family member (confirming good social background)
• Acute STEMI, defined as >30 minutes of continuous typical chest pain and ST-segment elevation ≥2 mm in two contiguous electrocardiography leads and /or left bundle branch block within 12 hours of symptom onset.
• Haemodynamically stable Angiographically
• Successful PPCI procedure (TIMI 2-3 flow and %<20 residual stenosis) and an uneventful 24 hour follow up period
• Single epicardial artery to be treated
• Telephone contact between the patient and PCI center after discharge is available 24 hours daily

Exclusion Criteria

• Inability to consent
• Patients treated with thrombolytic agents for the index STEMI
• Cardiogenic shock,
• Stroke within a month,
• Signs of heart failure (Killip II-IV)
• Hypotension (<100 mmHg SBP) persisting after PPCI
• Chest pain recurrence
• Clinically significant arrhythmia (requiring treatment) occurring >6 hours after PPCI.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acibadem University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sevket Gorgulu, MD

Role: STUDY_CHAIR

Acıbadem University School of Medicine

Tugrul Norgaz, MD

Role: PRINCIPAL_INVESTIGATOR

Acıbadem University School of Medicine

Sinan Dagdelen, MD

Role: PRINCIPAL_INVESTIGATOR

Acıbadem University School of Medicine

Nevzat Uslu, MD

Role: PRINCIPAL_INVESTIGATOR

Mehmet Akif Ersoy Education and Training Hospital

Aydin Yildirim, MD

Role: PRINCIPAL_INVESTIGATOR

Siyami Ersek Educational and Training Hospital

Ali Buturak, MD,

Role: PRINCIPAL_INVESTIGATOR

Acıbadem University School of Medicine

Locations

Acibadem University

Istanbul, , Turkey (Türkiye)

Mehmet Akif Ersoy Education and Training Hospital

Istanbul, , Turkey (Türkiye)

Siyami Ersek Education and Training Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Other Identifiers

the EDAP PCI trial

Identifier Type: -

Identifier Source: org_study_id