NCT02023983

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 30, 2017

Completed
Last Updated

December 6, 2017

Status Verified

October 1, 2017

Enrollment Period

3.3 years

First QC Date

December 16, 2013

Results QC Date

August 1, 2017

Last Update Submit

October 18, 2017

Conditions

Coronary Artery DiseaseAcute Myocardial Infarction With ST-segment ElevationPrimary Percutaneous Coronary InterventionEarly Discharge

Keywords

ST-segment elevation myocardial infarctionPrimary percutaneous coronary interventionLow riskEarly discharge

Outcome Measures

Primary Outcomes (1)

  • Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI)

    Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p \< 0.05 were considered as statistically significant.

    90 days

Secondary Outcomes (1)

  • Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)

    30 days

Study Arms (2)

Early discharge

EXPERIMENTAL
Other: Early discharge

Standard discharge

ACTIVE COMPARATOR
Other: Standard discharge

Interventions

Early dischargeOTHER

Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention

Early discharge
Standard dischargeOTHER

Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)

Standard discharge

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Municipal Hospital Ostrava

Ostrava, 728 80, Czechia

Location

Related Publications (1)

  • Novobilsky K, Stipal R, Cerny P, Horak I, Kaucak V, Mrozek J, Vaclavik J, Kryza R. Safety of early discharge in low risk patients after acute ST-segment elevation myocardial infarction, treated with primary percutaneous coronary intervention. Open label, randomized trial. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Feb;163(1):61-66. doi: 10.5507/bp.2018.041. Epub 2018 Aug 28.

    PMID: 30181666DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Limitations and Caveats

The limitation of the study is limited number of probands enrolled in one centre.

Results Point of Contact

Title
dr. Kamil Novobílský
Organization
Municipal Hospital Ostrava
k.novobilsky@mnof.cz
+420 59 619 2660

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 30, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2017

Study Completion

May 1, 2017

Last Updated

December 6, 2017

Results First Posted

August 30, 2017

Record last verified: 2017-10

Locations

CZ(1)