NCT02670005

Brief Summary

To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI) assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous coronary intervention (PCI).

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

July 26, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

January 26, 2016

Last Update Submit

July 24, 2016

Conditions

Fractional Flow ReserveST-segment Elevation Myocardial InfarctionPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons

    up to 5 years

Secondary Outcomes (3)

  • cardiac death

    up to 5 years

  • reinfarction

    up to 5 years

  • unplanned hospitalization due to cardiovascular reasons

    up to 5 years

Study Arms (2)

FFR-PCI group

patients with ST-segment elevation myocardial infarction (STEMI) who received fractional flow reserve (FFR)-guided selective percutaneous coronary intervention (PCI)

angiography-PCI group

patients with STEMI who received angiography-guided selective PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with ST-segment elevation myocardial infarction received selective percutaneous coronary intervention

You may qualify if:

  • age\>18 years
  • documented acute ST-segment elevation myocardial infarction
  • onset of symptom \>6 days before percutaneous coronary intervention
  • eligible for PCI

You may not qualify if:

  • cardiogenic shock or hemodynamic instability
  • highly tortuous or calcified arteries
  • infarct related artery with a diameter \< 2.5mm
  • a life expectancy\< 2 years
  • intolerance to anti-platelet drugs
  • left main disease (≥ 50% stenosis)
  • contraindication to adenosine
  • hypertrophic cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 1, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Last Updated

July 26, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share