Long Term Excess Mortality of Acute Myocardial Infarction... | NCT02591576

Studies
Long Term Excess Mortality of Acute Myocardial Infarction in Patients With and Without Diabetes: A Population-based Cohort Study

NCT02591576

Sponsor

University of Leeds

Status

Completed

Last Update Posted

Oct 29, 2015Estimated

Enrollment

700,000Actual

Phase

Not provided

Conditions

Effect of Diabetes on Long Term Excess Mortality Following Acute Myocardial Infarction

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Jul 2013Actual

Completion Date

Not provided

First Submitted Date

Oct 28, 2015

First Submission Date that Met QC Criteria

Oct 28, 2015

First Posted Date

Oct 29, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2015

Last Update Posted Date

Oct 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Diabetes is key risk factor for death following acute myocardial infarction. However, the long-term excess risk of death associated with diabetes following acute myocardial infarction not known. Investigators aimed to determine the long-term excess risk of death associated with diabetes among patients with ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) after adjustment for multimorbidity, risk factors and cardiac treatments.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

700,000Actual

Measure	Description	Time Frame
Long term excess mortality		8 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute myocardial infarction
Both sex
18 years

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

STEMI and NSTEMI were eligible for analysis if they have been hospitalised following AMI between the period of 2003-2013 and were aged at least 18 years. Only records of the first admission were considered for analyses.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27307468	Derived	Alabas OA, Hall M, Dondo TB, Rutherford MJ, Timmis AD, Batin PD, Deanfield JE, Hemingway H, Gale CP. Long-term excess mortality associated with diabetes following acute myocardial infarction: a population-based cohort study. J Epidemiol Community Health. 2017 Jan;71(1):25-32. doi: 10.1136/jech-2016-207402. Epub 2016 Jun 15.

ID	Term
D003920	Diabetes Mellitus
D000072657	ST Elevation Myocardial Infarction
D000072658	Non-ST Elevated Myocardial Infarction

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Label	Type	Description	Intervention Names
ST-elevation myocardial infarction (STEMI)
non-ST-elevation myocardial infarction (NSTEMI)