Trial Outcomes & Findings for Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial Infarction (NCT NCT02023983)

NCT ID: NCT02023983

Last Updated: 2017-12-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

151 participants

Primary outcome timeframe

90 days

Results posted on

2017-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Early Discharge Early discharge: 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	Standard Discharge Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
Overall Study STARTED	76	75
Overall Study COMPLETED	76	75
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Discharge n=76 Participants Early discharge: 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	Standard Discharge n=75 Participants Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)	Total n=151 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=76 Participants	0 Participants n=75 Participants	0 Participants n=151 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=76 Participants	56 Participants n=75 Participants	114 Participants n=151 Participants
Age, Categorical >=65 years	18 Participants n=76 Participants	19 Participants n=75 Participants	37 Participants n=151 Participants
Sex: Female, Male Female	15 Participants n=76 Participants	12 Participants n=75 Participants	27 Participants n=151 Participants
Sex: Female, Male Male	61 Participants n=76 Participants	63 Participants n=75 Participants	124 Participants n=151 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Hypertension	41 Participants n=76 Participants	41 Participants n=75 Participants	82 Participants n=151 Participants
Diabetes	7 Participants n=76 Participants	7 Participants n=75 Participants	14 Participants n=151 Participants
Impaired glucose tolerance	8 Participants n=76 Participants	12 Participants n=75 Participants	20 Participants n=151 Participants
Hyperliporoteinemia	54 Participants n=76 Participants	58 Participants n=75 Participants	112 Participants n=151 Participants
Previous myocardial infarction	3 Participants n=76 Participants	6 Participants n=75 Participants	9 Participants n=151 Participants
Previous PCI	2 Participants n=76 Participants	6 Participants n=75 Participants	8 Participants n=151 Participants
Previous stroke / transient ischemic attack	2 Participants n=76 Participants	2 Participants n=75 Participants	4 Participants n=151 Participants
Peripheral arterial disease	2 Participants n=76 Participants	1 Participants n=75 Participants	3 Participants n=151 Participants
Smoking	56 Participants n=76 Participants	45 Participants n=75 Participants	101 Participants n=151 Participants
Body-mass index	29.9 kg/m^2 STANDARD_DEVIATION 5.1 • n=76 Participants	27.3 kg/m^2 STANDARD_DEVIATION 3.5 • n=75 Participants	28.64 kg/m^2 STANDARD_DEVIATION 4.3 • n=151 Participants

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Outcome measures
Measure	Early Discharge n=76 Participants Early discharge: 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	Standard Discharge n=75 Participants Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
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) Primary composite endpoint	5 Participants	6 Participants
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) Death	0 Participants	0 Participants
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) Myocardial infarction	1 Participants	2 Participants
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) Unstable angina	1 Participants	1 Participants
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) Unplanned rehospitalization	5 Participants	6 Participants
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) Repeated target vessel revascularization	1 Participants	3 Participants
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) Stent thrombosis	0 Participants	2 Participants
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) Stroke	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Early Discharge n=76 Participants Early discharge: 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	Standard Discharge n=75 Participants Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)	1 Participants	0 Participants

Adverse Events

Early Discharge

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Discharge

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Early Discharge n=76 participants at risk Early discharge: 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	Standard Discharge n=75 participants at risk Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
Cardiac disorders Myocardial infarction	1.3% 1/76 • Number of events 1 • 90 days Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions	2.7% 2/75 • Number of events 2 • 90 days Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions
Cardiac disorders Unstable angina	1.3% 1/76 • Number of events 1 • 90 days Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions	1.3% 1/75 • Number of events 1 • 90 days Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer	0.00% 0/76 • 90 days Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions	1.3% 1/75 • Number of events 1 • 90 days Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions
Musculoskeletal and connective tissue disorders Chest pain	3.9% 3/76 • Number of events 3 • 90 days Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions	2.7% 2/75 • Number of events 2 • 90 days Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions

Other adverse events

Other adverse events
Measure	Early Discharge n=76 participants at risk Early discharge: 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	Standard Discharge n=75 participants at risk Standard discharge: Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
Vascular disorders Radial artery occlusion	1.3% 1/76 • Number of events 1 • 90 days Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions	0.00% 0/75 • 90 days Definitions of adverse event and serious adverse event meet the clinicaltrials.gov Definitions

Additional Information

dr. Kamil Novobílský

Municipal Hospital Ostrava

Phone: +420 59 619 2660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place