NCT04357314

Brief Summary

In late December 2019, an emerging disease due to a novel coronavirus (named SARS-CoV-2) rapidly spread in China and outside. France is currently facing the COVID-19 wave with more than 131 863 confirmed cases and almost 25 201 deaths. Systems of care have been reorganized in an effort to preserve hospital bed capacity, resources, and avoid exposure of patients to the hospital environment where COVID-19 may be more prevalent. Therefore, elective procedures of catheterization and programmed hospitalizations have been delayed. However, a significant proportion of procedures within the catheterization laboratory such as ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction or unstable angina are mandatory and cannot be postponed. Surprisingly, invasive cardiologist noticed a drop in STEMI volume without reliable data to confirm this impression. Furthermore, a recent single center report in Hong Kong pointed out longer delays of taking care when compared to patients with STEMI treated with percutaneous intervention the previous year. These data are at major concern because delay in seeking care or not seeking care could have detrimental impact on outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

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

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

April 19, 2020

Last Update Submit

August 17, 2020

Conditions

Myocardial Infarction

Keywords

Emergency care

Outcome Measures

Primary Outcomes (2)

  • The primary endpoint is a composite of death from all causes and mechanical complications of acute myocardial infarction (MI)

    Free wall rupture, acute ischemic mitral regurgitation, ventricular septal rupture

    3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

  • Rates of patients presenting with acute myocardial infarction

    Compare the number of patients presenting to cardiology department with acute myocardial infarction in 2019 versus in 2020

    3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

Secondary Outcomes (8)

  • Patient profile during admission for acute myocardial infarction

    3 months (between March 1 to May 31

  • Medical care times analysis

    3 months (between March 1 to May 31)

  • Medical care times analysis

    3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

  • Clinical evolution of patients

    3 months (between March 1 to May 31)

  • Clinical evolution of patients

    3 months (between March 1 to May 31, 2019 and between March 1 to May 31, 2020 )

  • +3 more secondary outcomes

Study Arms (2)

Patients with STEMI in 2019

Patient with acute myocardial infarction between March 17, 2019 and April17, 2019

Patients with STEMI in 2020

Patient with acute myocardial infarction between March 17, 2020 and April17, 2020.

Eligibility Criteria

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

Patients presenting to the hospital with acute coronary syndrome

You may qualify if:

  • Patients admitted on coronary angiography room for acute coronary syndrome with ST segment elevation defined by the following criteria:
  • Symptoms suggestive of myocardial ischemia (ex: persistent chest pain) AND
  • An elevation of the ST segment (measured from point J) visible on at least two contiguous leads with an elevation ≥ 2.5 millimeters in men \<40 years, or ≥ 2 millimeters in men ≥ 40 years, or ≥ 1.5 millimeters in women in V2-V3 leads and / or ≥ 1 millimeter in other leads (in the absence of branch block).

You may not qualify if:

  • \- 121/5000
  • Contraindication to invasive management related to the general condition of the patient.
  • Minors
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Guillaume CAYLA, MD

    Hôpital Universitaire Carémeau

    STUDY DIRECTOR

  • Guillaume BONNET, MD

    Inserm 970

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 22, 2020

Study Start

March 1, 2020

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)