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Trial · NCT01924442

ROOBY Trial Follow-up Extension

NCT01924442, Completed, VA Office of Research and Development; results first posted 2019-06-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. ROOBY Trial Follow-up Extension. Trials, record NCT01924442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01924442

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
ROOBY Trial Follow-up Extension
NCT number
NCT01924442
Status
Completed
Enrollment
2,203 participants, actual
Lead sponsor
VA Office of Research and Development
Conditions
All Cause Mortality, MACE
First posted
2013-08-16
Last updated
2019-06-07
Results first posted
2019-06-07

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryLong-term All Cause Mortality Between On-pump and Off-pump Patients.5 Years
Five-year mortality was initially assessed by matching the participants in the follow-up study to data in the VA Vital Status File and the National Death Index, which provided cause-of-death codes according to the International Classification of Diseases, 10th Revision.
SecondaryLong-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump Patients5 yearsSecondary outcomes included the 5-year rates of death from cardiac causes, repeat revascularization and nonfatal myocardial infarction.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYLong-term All Cause Mortality Between On-pump and Off-pump Patients.5 YearsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYLong-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump Patients5 yearsParticipantsCOUNT_OF_PARTICIPANTS

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Long-term All Cause Mortality Between On-pump and Off-pump Patients.On-PumpAll cause death131Participants
Long-term All Cause Mortality Between On-pump and Off-pump Patients.Off-PumpAll cause death168Participants
Long-term All Cause Mortality Between On-pump and Off-pump Patients.On-PumpComposite MACE outcome with death298Participants
Long-term All Cause Mortality Between On-pump and Off-pump Patients.Off-PumpComposite MACE outcome with death342Participants
Long-term All Cause Mortality Between On-pump and Off-pump Patients.On-PumpNo MACE outcome670Participants
Long-term All Cause Mortality Between On-pump and Off-pump Patients.Off-PumpNo MACE outcome594Participants
Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump PatientsOn-PumpDeath from cardiac causes58Participants
Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump PatientsOff-PumpDeath from cardiac causes70Participants
Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump PatientsOn-PumpAcute myocardial infarction105Participants
Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump PatientsOff-PumpAcute myocardial infarction134Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDOn-Pump1,099
Overall StudySTARTEDOff-Pump1,104
Overall StudyCOMPLETEDOn-Pump1,059
Overall StudyCOMPLETEDOff-Pump967
Overall StudyNOT COMPLETEDOn-Pump40
Overall StudyNOT COMPLETEDOff-Pump137

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
seriousDeath from cardiac causesCardiac disordersOn-Pump581,09958
seriousDeath from cardiac causesCardiac disordersOff-Pump701,10470
seriousAcute myocardial infarctionCardiac disordersOn-Pump1051,099105
seriousAcute myocardial infarctionCardiac disordersOff-Pump1341,104134
seriousRepeat revascularization procedureCardiac disordersOn-Pump1311,099131
seriousRepeat revascularization procedureCardiac disordersOff-Pump1451,104145
seriousPercutaneous coronary interventionCardiac disordersOn-Pump1271,099127
seriousPercutaneous coronary interventionCardiac disordersOff-Pump1311,104131
seriousRepeat Coronary artery bypass grafting (CABG)Cardiac disordersOn-Pump51,0995
seriousRepeat Coronary artery bypass grafting (CABG)Cardiac disordersOff-Pump161,10416

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityOn-Pump1311,099
Total, all-cause mortalityOff-Pump1681,104
Total, other adverse eventsOn-Pump01,099
Total, other adverse eventsOff-Pump01,104
Total, serious adverse eventsOn-Pump4261,099
Total, serious adverse eventsOff-Pump4961,104

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
28813218DERIVEDPubMed
35171210DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
On-Pump vs Off-Pump: deaths from any causeTrial comparisons
On-Pump vs Off-Pump: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01924442

GET https://conductscience.org/api/trials/v1/NCT01924442/registered