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ARgentinean Risk Assessment Registry in ACS; the ARRA-RACS Study (ARRA-RACS)

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: NCT01377402
Recruitment Status : Completed
First Posted : June 21, 2011
Results First Posted : December 17, 2015
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Universidad Católica de Salta
Information provided by (Responsible Party):
Helse Stavanger HF

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Chest Pain
Coronary Artery Disease
Unstable Angina Pectoris
Myocardial Infarction
Enrollment 982
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With Suspected Acute Coronary Chest Pain
Hide Arm/Group Description Men and women admitted with chest pain and suspected acute coronary syndrome (ACS).
Period Title: Overall Study
Started 982
Completed 982
Not Completed 0
Arm/Group Title Patients With Suspected Acute Coronary Chest Pain
Hide Arm/Group Description Patients recruited immediately following acute hospital admission for suspected coronary chest pain.
Overall Number of Baseline Participants 982
Hide Baseline Analysis Population Description
Patients with suspected ACS.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 982 participants
<=18 years
0
   0.0%
Between 18 and 65 years
544
  55.4%
>=65 years
438
  44.6%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 982 participants
62
(53 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 982 participants
Female
394
  40.1%
Male
588
  59.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Argentina Number Analyzed 982 participants
982
1.Primary Outcome
Title Total Mortality.
Hide Description Mortality for any reason
Time Frame 2-5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with suspected ACS
Arm/Group Title Patients With Suspected ACS
Hide Arm/Group Description:
Patients with acute hospitalisation due to suspected coronary chest pain.
Overall Number of Participants Analyzed 982
Measure Type: Number
Unit of Measure: participants
173
2.Secondary Outcome
Title Participants With Cardiac Events During Follow-up.
Hide Description Cardiovascular Death. Myocardial infarctions (re-MIs) defined according to WHO criteria of 1979.
Time Frame 2-5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiovascular Death Myocardial Re-infarction
Hide Arm/Group Description:
Patients with confirmed cardiovascular death during the course of the study
Patients with one or more myocardial re-infarctions during the course of the study
Overall Number of Participants Analyzed 982 982
Measure Type: Number
Unit of Measure: Participants
92 51
Time Frame [Not Specified]
Adverse Event Reporting Description The study subjects were interviewed at pre-dedetermined intervals from inclusion until end of follow-up.
 
Arm/Group Title Patients With Suspected ACS
Hide Arm/Group Description Patients admitted to hospital with acute chest pain.
All-Cause Mortality
Patients With Suspected ACS
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Patients With Suspected ACS
Affected / at Risk (%)
Total   0/982 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With Suspected ACS
Affected / at Risk (%)
Total   0/982 (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: Dennis WT Nilsen, MD, phd, professor
Organization: Stavanger University Hospital
Phone: +4795777735
EMail: dnilsen1@getmail.no
Publications of Results:
Layout table for additonal information
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01377402    
Other Study ID Numbers: ARRA-RACS
First Submitted: June 20, 2011
First Posted: June 21, 2011
Results First Submitted: July 28, 2015
Results First Posted: December 17, 2015
Last Update Posted: May 2, 2017