- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00611169
The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction
February 7, 2008 updated by: Samsung Medical Center
The Effects of Facilitated Percutaeous Coronary Intervention Compared to Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Acute Myocardial Infarction
The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
- ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage
Exclusion Criteria:
- hemodynamic instability
- history of MI
- old age > 80years
- Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose
|
tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)
|
No Intervention: 2
Aspirin, clopidogrel, unfractionated heparin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infarct size and its transmural extent using MRI
Time Frame: within the first 30 days after index procedure
|
within the first 30 days after index procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography
Time Frame: at 6 month after index procedure
|
at 6 month after index procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
January 27, 2008
First Submitted That Met QC Criteria
February 7, 2008
First Posted (Estimate)
February 8, 2008
Study Record Updates
Last Update Posted (Estimate)
February 8, 2008
Last Update Submitted That Met QC Criteria
February 7, 2008
Last Verified
August 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-09-007-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myocardial Infarction
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Henry Ford Health SystemAbiomed Inc.Enrolling by invitationAcute Myocardial Infarction | Cardiogenic Shock | STEMI | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial Infarction | NSTEMI | Acute Myocardial Infarction With ST Elevation | Acute Myocardial Infarction of Right Ventricle (Disorder) | Acute Myocardial Infarction of Left VentricleUnited States
-
Jordan Collaborating Cardiology GroupCardiovascular Academy GroupTerminatedTriggers of Acute Myocardial Infarction | Time of Onset of Acute Myocardial Infarction | Long-term Prognosis After Acute Myocardial InfarctionJordan
-
Recardio, Inc.CompletedAcute Myocardial Infarction | STEMI - ST Elevation Myocardial Infarction | Acute Myocardial IschemiaNetherlands, Hungary, Austria, Poland, Belgium
-
Medical Center of South ArkansasWithdrawnAcute Coronary Syndrome | Acute ST Segment Elevation Myocardial InfarctionUnited States
-
Yuan's General HospitalKaohsiung Veterans General Hospital.; Sin-Lau HospitalUnknownAcute Myocardial Infarction, of Inferolateral Wall | Acute Myocardial Infarction, of Inferoposterior WallTaiwan
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Acute Coronary Syndrome | Acute Myocardial Infarction | Metabolic DisturbanceGreece
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
Sheba Medical CenterCompletedNon ST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
-
Medstar Health Research InstituteWithdrawnST-elevation Myocardial Infarction | Acute Myocardial InfarctionUnited States
-
Hennepin Healthcare Research InstituteSiemens HealthineersActive, not recruitingAcute Coronary Syndrome | Acute Myocardial InfarctionUnited States
Clinical Trials on tirofiban
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Hospices Civils de LyonCompletedAcute Myocardial InfarctionFrance
-
Beijing Tiantan HospitalNot yet recruitingTIA | Ischemic Stroke, Acute | Symptomatic Intracranial Artery StenosisChina
-
MedicureSCRI Development Innovations, LLCCompletedMyocardial Infarction | Unstable Angina | Acute Coronary SyndromesUnited States
-
The First Hospital of Jilin UniversityNot yet recruitingAcute Ischemic Stroke
-
University of IowaWithdrawnIschemic Stroke | Acute Ischemic StrokeUnited States
-
Shanghai East HospitalJinan Central Hospital; Ningbo No. 1 Hospital; Shanghai 6th People's Hospital; Shanghai... and other collaboratorsCompletedIschemic StrokeChina
-
Second Hospital of Jilin UniversityUnknownCoronary Artery DiseaseChina
-
Beijing Anzhen HospitalUnknown
-
Kosuyolu Heart HospitalThe Society of Cardiac Health ProtectionCompletedAcute Myocardial Infarction
-
Capital Medical UniversityRecruiting