NCT00529607

Brief Summary

The primary purpose of this study is to correlate new cardiac imaging modalities (2D, 3D echocardiography, contrast echocardiography, strain analysis and cardiac MRI) to biochemical parameters as the L-arginine-nitric oxide pathway and inflammatory cascades to characterize the reperfusion injury following myocardial infarction and thus providing a basis for further diagnostic and therapeutic approaches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

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

September 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 20, 2009

Status Verified

March 1, 2009

Enrollment Period

1.5 years

First QC Date

September 12, 2007

Last Update Submit

March 19, 2009

Conditions

Reperfusion Injury

Keywords

myocardial infarction, reperfusion injury, echocardiography, magnetic resonance imaging, inflammation, nitric oxide

Study Arms (3)

1

\- patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery

Drug: contrast echocardiographyProcedure: 2D and 3D echocardiographyProcedure: cardiac MRIProcedure: blood sampling

2

\- 30 patients with stable CAD (control group 1)

Procedure: blood sampling

3

\- 30 healthy volunteers regarding cardiovascular diseases (control group 2)

Procedure: blood sampling

Interventions

contrast echocardiographyDRUG

directly after PCI, at 24 h after PCI, before discharge and at 6 months

Also known as: with luminity or sonovue
1
2D and 3D echocardiographyPROCEDURE

directly after PCI, at 24 h after PCI, before discharge and at 6 months

1
cardiac MRIPROCEDURE

before discharge and after 6 months

1
blood samplingPROCEDURE

routine lab work plus infarction and inflammation biomarkers 1: before PCI, after PCI, at 34 hours, at discharge, at 6 months 2 and 3: one blood sample in total before PCI in 2 and at any time in 3

123

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery (first myocardial infarction and recurrent myocardial infarction, as long as infarct-related artery is occluded for the first time) * written informed consent or 30 patients with stable CAD (control group 1) or 30 healthy volunteers regarding cardiovascular diseases (control group 2)

You may qualify if:

  • patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery (first myocardial infarction and recurrent myocardial infarction, as long as infarct-related artery is occluded for the first time)
  • written informed consent
  • or 30 patients with stable CAD (control group 1) or 30 healthy volunteers regarding cardiovascular diseases (control group 2)

You may not qualify if:

  • minors
  • incompetent persons
  • pregnant and lactating
  • moderate to severe renal insufficiency defined by an GFR \< 60 ml/kg/m2
  • missing written consent
  • other reasons complicating a clinical reevaluation and/or coronary angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (1)

  • Kehmeier ES, Lepper W, Kropp M, Heiss C, Hendgen-Cotta U, Balzer J, Neizel M, Meyer C, Merx MW, Verde PE, Ohmann C, Heusch G, Kelm M, Rassaf T. TNF-alpha, myocardial perfusion and function in patients with ST-segment elevation myocardial infarction and primary percutaneous coronary intervention. Clin Res Cardiol. 2012 Oct;101(10):815-27. doi: 10.1007/s00392-012-0465-x. Epub 2012 May 6.

    PMID: 22562290DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biomarkers for Infarction and Inflammation

MeSH Terms

Conditions

Reperfusion InjuryMyocardial InfarctionInflammation

Interventions

perflutrencontrast agent BR1Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesInfarctionIschemiaNecrosis

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Wolfgang Lepper

    Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2007

First Posted

September 14, 2007

Study Start

September 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 20, 2009

Record last verified: 2009-03

Locations

DE(1)