Surveillance of Patients With Suspected Acute Myocardial... | NCT02194153

Studies
Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Early Inhospital Thrombolysis With Metalyse

NCT02194153

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 18, 2014Estimated

Enrollment

351Actual

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

Metalyse weight-adjusted

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2001

Primary Completion Date

Mar 2003Actual

Completion Date

Not provided

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Jul 17, 2014

First Posted Date

Jul 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2014

Last Update Posted Date

Jul 18, 2014Estimated

Description Module

Brief Summary

Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse® in a real life setting outside clinical trials.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

351Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metalyse		Metalyse weight-adjusted	Drug: Metalyse weight-adjusted

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metalyse weight-adjusted	Drug		Metalyse

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete ST-segment resolution		up to 30 days
Pain relief	yes/no question	90 min, 120 min, up to 30 days after treatment initiation
Change in creatine kinase (CK)		up to 24 hours
Change in creatine kinase-MB (CK-MB)		up to 24 hours
Change in troponin		up to 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Male and female patient with suspected myocardial infarction, e.g. during transportation to the hospital by ambulance. No patient younger than 18 years.
Possibility of obtaining relevant information concerning indication or contraindication of thrombolysis in each patient
Typical chest pain with a duration of more than 30 minutes
Definite infarction signs in a 12-lead-ECG with ST-elevation > 0.1 millivolt (mV) in > 2 leads or recent left bundle branch block with typical clinical signs
Symptom onset <= 6 hours

Exclusion criteria:

Patients older than 75 years (exception: patients appear much younger)
Low body weight
No persons under 18
contraindications according to summary of product characteristics (SPC) for Metalyse

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

prehospital or emergency room patients

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided