Full Text View
Tabular View
No Study Results Posted
Related Studies
Endothelin Receptor Blockade in Acute ST-Elevation Myocardial Infarction
This study is currently recruiting participants.
Verified by Medical University of Vienna, May 2008
First Received: July 16, 2007   Last Updated: May 20, 2008   History of Changes
Sponsored by: Medical University of Vienna
Information provided by: Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00502528
  Purpose

Background and Objective: Acute coronary syndrome is characterized by compromised blood flow at the epicardial and microvascular levels. The aim of the present study is to investigate the effect of ET-receptor blockade by BQ-123 on myocardial perfusion and infarct size as an adjunct to PCI-reperfusion therapy in patients with STEMI. Patients are randomized to receive periinterventional intravenous BQ-123 or placebo.


Condition Intervention Phase
ST-Elevation Myocardial Infarction
 Drug: Placebo
Drug: BQ-123
 Phase II

MedlinePlus related topics: Heart Attack
Drug Information available for: BQ 123
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Endothelin Receptor Blockade in Acute ST-Elevation Myocardial Infarction

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Myocardial perfusion determined by CMR [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Final infarct size determined by CMR [ Time Frame: 3 days/ 6 months ] [ Designated as safety issue: No ]
  • Left ventricular function determined by CMR [ Time Frame: 3 days/ 6 months ] [ Designated as safety issue: No ]
  • Plasma NT-BNP [ Time Frame: 30 days/ 6 months ] [ Designated as safety issue: No ]
  • Area under the curve of CK-MB levels estimating infarct size [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • ECG ST-segment resolution [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 24 hours/ 30 days ] [ Designated as safety issue: No ]
  • major adverse cardiac events (MACE) (cardiovascular death, re-hospitalization for unstable angina and AMI, hospitalization for worsening heart failure) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Liver function [ Time Frame: 24hours/ 3 days/ 30 days ] [ Designated as safety issue: Yes ]
  • Event free survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Remodeling determined by MRT [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
Placebo
Drug: Placebo
Peri-interventional
2: Active Comparator
BQ-123
Drug: BQ-123
Peri-interventional

Detailed Description:

Background and Objective: Acute coronary syndrome is characterized by compromised blood flow at the epicardial and microvascular levels. We have previously shown that thrombectomy in ST-elevation myocardial infarction (STEMI) accelerates ST-segment resolution, possibly by preventing distal embolization. Therefore, we analyzed the vasoconstrictor concentration of acute coronary thrombi, and found high concentrations of endothelin (ET) which correlated with the magnitude of ST-segment resolution within one hour of percutaneous coronary intervention (PCI). Furthermore, ET-receptor blockade by tezosentan significantly repressed vasoconstriction in an in-vitro model using porcine coronary artery rings incubated with coronary thrombus homogenates extracted from STEMI patients. The aim of the present study is to investigate the effect of ET-receptor blockade by BQ-123 on myocardial perfusion and infarct size as an adjunct to PCI-reperfusion therapy in patients with STEMI. Methods: Fifty eligible patients will be randomized to receive periinterventional intravenous BQ-123 or placebo. The primary endpoint of the study will be microvascular function and infarct size evaluated by cardiac magnetic resonance tomography.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • STEMI patients (defined as: Evidence of ischemic chest pain for >30 minutes within <12 hours and new ST-segment elevation for ≥2 mm in two or more contiguous electrocardiographic leads or in case of a true posterior infarction reciprocal ST-segment depressions in in V1 and V2 >1mm and/or elevated serum creatine phosphokinase or twofold elevation of troponin-T), aged 18 years and above, who undergo primary percutaneous revascularization (PCI) and have confirmed initial TIMI 0 or 1 in the infarct related coronary artery.

Exclusion Criteria:

  • Significant liver disease
  • Thrombolytic therapy
  • History of prior myocardial infarction
  • Current atrial fibrillation
  • History of congestive heart failure
  • History of migraine headache
  • Significant valvular heart disease, primary myocardial disease
  • Cardiogenic shock (sRR <90mmHg or need for inotropic support)
  • Child-bearing potential
  • Inability to read, understand and sign the informed consent
  • Life expectancy <3y
  • Prior organ transplantation
  • Medication with konazoles, ritonavir, rifampicin and sulfonyl-urea derivatives
  • Participation in another clinical study
  • Metal implants contraindicating CMR
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502528

Contacts
Contact: Irene M Lang, MD 0043 40400 ext 4614 irene.lang@meduniwien.ac.at
Contact: Christopher Adlbrecht, MD 0043 40400 ext 4614 christopher.adlbrecht@meduniwien.ac.at

Locations
Austria, Vienna-Austria
Medical University of Vienna Recruiting
Vienna, Vienna-Austria, Austria, 1090
Contact: Irene Lang, MD     +43 1 40400 ext 4614     irene.lang@meduniwien.ac.at    
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Irene M Lang, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Medical University of Vienna ( Irene Lang )
Study ID Numbers: BQ123AMI12/06
Study First Received: July 16, 2007
Last Updated: May 20, 2008
ClinicalTrials.gov Identifier: NCT00502528     History of Changes
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Infarction, Endothelin, Perfusion

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
 Cyclo(Trp-Asp-Pro-Val-Leu)
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
 Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services