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Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction

K

Kamil Novobílský

Status

Completed

Conditions

Coronary Artery Disease
Acute Myocardial Infarction With ST-segment Elevation
Early Discharge
Primary Percutaneous Coronary Intervention

Treatments

Other: Standard discharge
Other: Early discharge

Study type

Interventional

Funder types

Other

Identifiers

NCT02023983
KN-11-2013

Details and patient eligibility

About

The aim of the study is to prove that early discharge (within 72 hours) in selected group of patients after myocardial infarction with elevations of ST-segment is feasible and safe

Full description

The aim of the study is to prove

  • that early discharge (within 72 hours) in selected group of patients with low risk of follow-up complications after myocardial infarction with elevations of ST-segment, treated with primary percutaneous coronary intervention, is feasible and safe
  • that early discharge is comparable with the group of patients, discharged in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day), thus it is not associated with higher incidence of complications in 90th day after myocardial infarction

Enrollment

151 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent
  • Age ≥18 do ≤ 75 years
  • Acute myocardial infarction with ST-segment elevation, treated with successful percutaneous coronary intervention within 12 hours from the onset of symptoms
  • Left ventricle ejection fraction ≥ 45% by echocardiography
  • Single- or two-vessel disease (stenosis of major epicardial artery ≥ 70%)
  • Haemodynamic and rhythmic stability (Killip class I, no arrythmia requiring treatment occurring > 2 hours after PCI)
  • Assumed good cooperation and social background

Exclusion criteria

  • Symptoms of residual ischemia
  • Significant comorbidities or abnormalities in paraclinical tests, requiring additional evaluation within continuing hospitalization
  • Contraindication of dual antiplatelet therapy or need for anticoagulation therapy
  • Hihg risk of bleeding complications
  • Participation in other clinical study

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

151 participants in 2 patient groups

Early discharge
Experimental group
Treatment:
Other: Early discharge
Standard discharge
Active Comparator group
Treatment:
Other: Standard discharge

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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