NCT01538303

Brief Summary

The purpose of this study is first to evaluate absolute myocardial blood flow and resistance over time in the acute and sub-acute phase of myocardial infarction and second, to correlate these parameters to preservation of left ventricular function and long-term outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

February 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

February 20, 2012

Last Update Submit

February 8, 2023

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

STEMIabsolute flowmicrovascular resistance

Study Arms (1)

measurement absolute flow and resistance

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients with STEMI either in our own hospital either referred by other hospitals or the ambulance.

You may qualify if:

  • STEMI \< 12 hours
  • \> 10mm ST-segment deviation
  • culprit lesion in proximal or mid segment of a coronary artery with a reference diameter \> 3.0mm by visual estimation.
  • hemodynamically stable.

You may not qualify if:

  • Age \> 75 years
  • cardiogenic shock or pre-shock
  • Patients in whom no access to the coronary circulation can be obtained by the femoral artery or in whom femoral access was problematic.
  • Patients with previous myocardial infarction in the culprit area of with previous bypass surgery
  • Tortuous coronary arteries or complex or long-lasting primary PCI
  • Severe concomitant disease or conditions with a life expectancy of less than one year
  • Inability to understand and give informed consent either in first instance on the table or in second instance on the coronary care unit.
  • Other known myocardial diseases, such as moderate or severe left ventricular hypertrophy or cardiomyopathy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Hospital Eindhoven

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nico Pijls, MD, PhD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 24, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 10, 2023

Record last verified: 2023-02

Locations

NL(1)