NCT02407002

Brief Summary

The purpose of this study is to quantify the risk of hypotension due to field treatment with nitroglycerin in patients with ST-elevation myocardial infarction, particularly right ventricular infarcts, and secondarily to evaluate the benefit to pain relief..

Trial Health

87
On Track

Trial Health Score

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

Enrollment
940

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

1.6 years

First QC Date

March 24, 2015

Last Update Submit

August 23, 2017

Conditions

Myocardial Infarction

Keywords

NitroglycerinSafety

Outcome Measures

Primary Outcomes (1)

  • Hypotension

    SBP \<100mmHg

    At ED arrival. This will be assessed at the end of the prehospital phase of care, taken from the first set of vital signs on arrival at the emergency department. Average transport 15 minutes.

Secondary Outcomes (2)

  • Pain Relief

    At ED arrival. This will be assessed at the end of the prehospital phase of care, taken from the first set of vital signs on arrival at the emergency department. Average transport 15 minutes.

  • Mortality

    At hospital discharge. Patients will be followed until hospital discharge, anticipated median 3 days.

Eligibility Criteria

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

The subjects will be patients with STEMI identified in the field and transported to a study site.

You may qualify if:

  • Identified by paramedics as having a STEMI.
  • Transported to a study site.

You may not qualify if:

  • Under 18 years of age
  • Primary complaint of trauma
  • Cardiac arrest upon EMS arrival
  • Transported to a non-study site
  • Transferred from another hospital
  • Hypotensive on EMS arrival

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UCLA Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Nichole Bosson, MD, MPH

    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 2, 2015

Study Start

June 1, 2015

Primary Completion

December 31, 2016

Study Completion

April 30, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations

US(3)