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Early Discharge After Primary Percutaneous Coronary Intervention (EDAPPCI)

Primary Purpose

ST Elevation Myocardial Infarction

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

early discharge

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring Early discharge, STEMI, PPCI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Acibadem University
Mehmet Akif Ersoy Education and Training Hospital
Siyami Ersek Education and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Early discharge group

Standard discharge group

Arm Description

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

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

Outcomes

Primary Outcome Measures

All Cause Mortality and Readmission at 30 Days.

The primary end points were all cause mortality by 1 month and readmission due to reinfarction, unstable angina, arrhythmia, congestive heart failure, revascularization, stroke or major bleeding at 1 month.

Secondary Outcome Measures

Full Information

NCT ID

NCT01860079

First Posted

May 16, 2013

Last Updated

March 9, 2016

Sponsor

Acibadem University

1. Study Identification

Unique Protocol Identification Number

NCT01860079

Brief Title

Early Discharge After Primary Percutaneous Coronary Intervention

Acronym

EDAPPCI

Official Title

Early Discharge After Primary Percutaneous Coronary Intervention: A Prospective Randomized Multi-center Trial (the EDAP PCI Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acibadem University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST Elevation Myocardial Infarction

Keywords

Early discharge, STEMI, PPCI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

900 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early discharge group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Standard discharge group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

early discharge

Intervention Description

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

Primary Outcome Measure Information:

Title

All Cause Mortality and Readmission at 30 Days.

Description

Time Frame

30 DAYS

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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.

Overall Study Officials: