NCT03099395

Brief Summary

Recurrent myocardial infarctions (reinfarctions) can be due to recurrence at the original treatment site, the presence of untreated lesions elsewhere, or in progressive lesions. There are scarce published data describing the localization (affected vessel/s) and severity (NSTE-ACS/STE-ACS) of reinfarction(s) compared to the index MI (e.g proportion of recurrent infarctions in the previously diseased vessel) in large unselected patient populations. If reinfarctions are generally more severe than index MI/recurrent MI(s), this might have implications for choice of treatment and treatment length. Moreover, data from unselected patient populations on the overall incidence pattern/rate of patients experiencing multiple reinfarctions is sparse. Patients who experience multiple ischemic events may be a subset of patients who are poor responders to therapy. There is also a possibility that patients with multiple events are less likely to have received evidence-based therapy such as coronary stenting, novel and more effective antithrombotics and modern lipid lowering treatment for the initial event. Poor adherence to secondary prevention measures (e.g. low compliance to medication and adherence to cardiac rehabilitation programs) may also increase the risk of recurrent events. Therefore identification of the baseline characteristics, including treatment decision strategies in the setting of a myocardial infarction, among such subjects may allow modifications of the clinical management strategy prior to the occurrence of subsequent ischemic events. Such modifications could include providing a more intensive or additional therapy in certain patient groups or find strategies to improve patient adherence and drug compliance. A patient with reinfarctions requires more hospitalizations, treatments, laboratory tests, and out-patient visits, resulting in overall increased costs. From the patient perspective, recurrent events result in higher mortality and worsened quality of life.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Status
unknown

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

June 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

March 28, 2017

Last Update Submit

April 3, 2017

Conditions

Keywords

myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Pattern of repeat cardiovascular events during follow-up after first diagnosed event-MI.

    max 8 years follow-up

Study Arms (1)

No re-MI, one re-MI, > one re-MI

From a population with MI surviving one year (78 468 pts) the number of pts with no re-MI, one re-MI or \> re-MI will be described.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients registered in SWEDHEART with an index-MI within the observation period.

You may qualify if:

  • Patients registered in SWEDHEART with an index-MI within the observation period

You may not qualify if:

  • Less than one year follow-up data
  • Previous MI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Varenhorst C, Hasvold P, Johansson S, Janzon M, Albertsson P, Leosdottir M, Hambraeus K, James S, Jernberg T, Svennblad B, Lagerqvist B. Culprit and Nonculprit Recurrent Ischemic Events in Patients With Myocardial Infarction: Data From SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies). J Am Heart Assoc. 2018 Jan 9;7(1):e007174. doi: 10.1161/JAHA.117.007174. Epub 2018 Jan 4.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
8 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 4, 2017

Study Start

June 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

April 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share