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Pattern of Repeat Cardiovascular Events During Follow-up After First Diagnosed Event-MI (PRECLUDE-MI)

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ClinicalTrials.gov Identifier: NCT03099395
Recruitment Status : Unknown
Verified April 2017 by Uppsala University.
Recruitment status was:  Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Uppsala University

Tracking Information
First Submitted Date March 28, 2017
First Posted Date April 4, 2017
Last Update Posted Date April 5, 2017
Actual Study Start Date June 1, 2015
Estimated Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 31, 2017)
Pattern of repeat cardiovascular events during follow-up after first diagnosed event-MI. [ Time Frame: max 8 years follow-up ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03099395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pattern of Repeat Cardiovascular Events During Follow-up After First Diagnosed Event-MI
Official Title Pattern of Repeat Cardiovascular Events During Follow-up After First Diagnosed Event-MI - PRECLUDE-MI - A Retrospective Cohort Study
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.

Detailed Description

This study will combine the SWEDEHEART registries RIKS-HIA (Registry of Information and Knowledge about Swedish Heart Intensive care Admissions), SCAAR (Swedish Coronary Angiography and Angioplasty Registry) and SEPHIA (the registry for secondary prevention following coronary intensive care); and the Swedish National Population Registry (to obtain data regarding vital status and date of death), Swedish Cause of Death Register (to separate fatal from non-fatal MI), the Swedish Patient Registry (to obtain data on prior medical history) and the Swedish Drug Registry (to obtain prescribed medical treatment and filled prescriptions).

The RIKS-HIA database covers all acute coronary syndrome (ACS) patients treated at heart intensive care units in Sweden and SCAAR entails all PCI procedures performed across all centers in Sweden.

In this study the investigators will include patients with first time ever of NSTE-ACS and STE-ACS and receiving care at cardiac intensive care units and entered in the SWEDEHEART registry between 1 July 2006 and 31 December 2014. Baseline and in-hospital characteristics will be obtained, including peri-procedural anti-thrombotic treatments.

To assess the incidence rate and fatality of reinfarctions in a contemporary unselected MI cohort

To characterize patients with one and multiple reinfarctions during the observation period vs. those without.

To characterize patients with one and multiple reinfarction during the observational period vs. those without.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 8 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients registered in SWEDHEART with an index-MI within the observation period.
Condition Myocardial Infarction
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: March 31, 2017)
100000
Original Actual Enrollment Same as current
Estimated Study Completion Date October 1, 2017
Estimated Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than one year follow-up data
  • Previous MI
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03099395
Other Study ID Numbers PRECLUDE-MI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Uppsala University
Study Sponsor Uppsala University
Collaborators AstraZeneca
Investigators Not Provided
PRS Account Uppsala University
Verification Date April 2017