Trial Outcomes & Findings for ARgentinean Risk Assessment Registry in ACS; the ARRA-RACS Study (NCT NCT01377402)

NCT ID: NCT01377402

Last Updated: 2017-05-02

Results Overview

Mortality for any reason

• Recruitment status: COMPLETED
• Target enrollment: 982 participants
• Primary outcome timeframe: 2-5 years
• Results posted on: 2017-05-02

Participant Flow

Participant milestones

Measure	Patients With Suspected Acute Coronary Chest Pain Men and women admitted with chest pain and suspected acute coronary syndrome (ACS).
Overall Study STARTED	982
Overall Study COMPLETED	982
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patients With Suspected Acute Coronary Chest Pain n=982 Participants Patients recruited immediately following acute hospital admission for suspected coronary chest pain.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	544 Participants n=5 Participants
Age, Categorical >=65 years	438 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	394 Participants n=5 Participants
Sex: Female, Male Male	588 Participants n=5 Participants
Region of Enrollment Argentina	982 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-5 years

Population: Patients with suspected ACS

Mortality for any reason

Outcome measures

Measure	Patients With Suspected ACS n=982 Participants Patients with acute hospitalisation due to suspected coronary chest pain.	Myocardial Re-infarction Patients with one or more myocardial re-infarctions during the course of the study
Total Mortality.	173 participants	—

SECONDARY outcome

Timeframe: 2-5 years

Cardiovascular Death. Myocardial infarctions (re-MIs) defined according to WHO criteria of 1979.

Outcome measures

Measure	Patients With Suspected ACS n=982 Participants Patients with acute hospitalisation due to suspected coronary chest pain.	Myocardial Re-infarction n=982 Participants Patients with one or more myocardial re-infarctions during the course of the study
Participants With Cardiac Events During Follow-up.	92 Participants	51 Participants

Adverse Events

Patients With Suspected ACS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dennis WT Nilsen, MD, phd, professor

Stavanger University Hospital

Phone: +4795777735

Email: dnilsen1@getmail.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place