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Trial record 62 of 228 for:    EDN1

Role of Endothelin in Microvascular Dysfunction Following PCI for NSTEMI (BQ-123)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00586820
Recruitment Status : Completed
First Posted : January 7, 2008
Results First Posted : July 4, 2014
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Myocardial Reperfusion Injury
Interventions Drug: BQ-123
Drug: Placebo
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BQ-123 Placebo
Hide Arm/Group Description The selective endothelin type A receptor antagonist (BQ-123) will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI). Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
Period Title: Overall Study
Started 12 11
Completed 11 11
Not Completed 1 0
Reason Not Completed
Unsuccessful PCI             1             0
Arm/Group Title BQ-123 Placebo Total
Hide Arm/Group Description BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI). Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI. Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
12 subjects were enrolled on the BQ-123 arm, but 1 subject was excluded due to unsuccessful PCI.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
64.5  (11.2) 64  (12.5) 64.27  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
4
  36.4%
2
  18.2%
6
  27.3%
Male
7
  63.6%
9
  81.8%
16
  72.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title Average Peak Velocity (APV) Immediately Following Percutaneous Coronary Intervention (PCI)
Hide Description Coronary microvascular blood flow will be assessed following successful PCI by measuring APV in the culprit vessel using Doppler echocardiography.
Time Frame immediately following PCI procedure
Hide Outcome Measure Data
Hide Analysis Population Description
One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.
Arm/Group Title BQ-123 Placebo
Hide Arm/Group Description:
BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
Overall Number of Participants Analyzed 11 11
Median (Inter-Quartile Range)
Unit of Measure: cm/s
30
(20 to 37)
19
(9 to 26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BQ-123, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Percent Change in Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) From Immediately Pre-PCI to 8 and 16 Hours Post-PCI
Hide Description CK-MB is a cardiac marker that can demonstrate the development of heart muscle necrosis resulting from an acute interruption of blood supply to a part of the heart. CK-MB is measured by a blood test.
Time Frame immediately pre-PCI, 8 hours post-PCI, 16 hours post-PCI
Hide Outcome Measure Data
Hide Analysis Population Description
One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.
Arm/Group Title BQ-123 Placebo
Hide Arm/Group Description:
BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
Overall Number of Participants Analyzed 11 11
Median (Inter-Quartile Range)
Unit of Measure: percent change
% Change immediate pre-PCI, 8 hr post-PCI
-17
(-26 to -10)
26
(-15 to 134)
% Change immediate pre-PCI, 16 hr post-PCI
-17
(-38 to 14)
107
(2 to 446)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BQ-123, Placebo
Comments Change between the groups from immediate pre-PCI and 8 hours post PCI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BQ-123, Placebo
Comments Change between the groups from immediate pre-PCI and 16 hours post-PCI.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BQ-123 Placebo
Hide Arm/Group Description BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI). Subjects randomized to the placebo arm will receive a placebo infusion for 20 minutes prior to PCI.
All-Cause Mortality
BQ-123 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BQ-123 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BQ-123 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amir Lerman
Organization: Mayo Clinic
Phone: 507-255-6670
EMail: lerman.amir@mayo.edu
Layout table for additonal information
Responsible Party: Amir Lerman, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586820     History of Changes
Other Study ID Numbers: 859-05
First Submitted: December 21, 2007
First Posted: January 7, 2008
Results First Submitted: April 21, 2014
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014