Ignite Creation Date:
2024-05-06 @ 3:52 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02399891
Status:
UNKNOWN
Last Update Posted:
2016-06-08
First Post:
2015-03-23
Brief Title:
Acute Myocardial Infarction Quality Assurance Project
Sponsor:
Dr Derek Exner
Organization:
University of Calgary
Study Overview
Official Title:
Acute Myocardial Infarction Quality Assurance Project
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMIQA
Brief Summary:
Cohort study aimed at evaluating the incidence of left ventricular LV dysfunction after myocardial infraction MI and assessing the prognostic utility of change in ejection fraction EF over the initial 12 months after MI
Detailed Description:
Background
Patients suffering a myocardial infraction MI may have from minimal to extensive myocardial damage While severe left ventricular LV dysfunction that persists beyond the initial 2-3 months of an MI is a predictor of sudden death the prognostic significance of less severe LV dysfunction after MI is unclear
There is significant clinical value in quantifying LV function after the recovery phase of an MI This information is vital in guiding the breadth and duration of therapies known to improve prognosis beta-blockers ACE inhibitors angiotensin blockers anticoagulants and others Further it will identify patients in whom other therapies such as an implantable cardioverter defibrillator ICD are recommended Yet no guidelines to guide clinical decision making in terms of collecting follow-up ejection fraction EF data in such patients who do not also have overt heart failure
Purpose The Acute Myocardial Infarction Quality Assurance AMIQA project proposes to
1 document clinical practice by collecting data on the proportion of patients with initial LV dysfunction after MI without a follow-up EF assessment arranged
2 collect follow-up EF data in patients with initial LV dysfunction post-MI and evaluate the prognostic significant of EF early and late after MI as well as factors associated with the change in value and
3 educate physicians regarding the importance of EF reassessment after MI
Follow up LV assessment
The current guidelines do not clearly provide clear indications to the appropriate timing or modality of follow up left ventricular assessments We have chosen to define an adequate follow up LV assessment to occur within 2 to 12 months post-myocardial infarction measured by any modality such as echocardiography cardiac MRI or nuclear perfusion scan
Overall Study Objectives
1 To evaluate the relationship of changes in EF after MI with clinical variables such as age gender co-morbid conditions MI characteristics and the prescription of pharmacological agents after MI
2 To assess the relationship of changes in EF after MI with clinical outcomes
Study Methodology and Data Collection
This study will be conducted in three phases
1 determining the existing practice of assessing left ventricular ejection fraction following myocardial infarction within the Calgary region Quality Assurance
2 determining the factors associated with LVEF improvement stability and decline post-MI and the relationship of these with outcome Prognostic Factor Study
3 educating the clinical community about the importance of follow up LVEF assessments and reporting the findings of this through presentations educational materials andor academic publications Knowledge Dissemination
Study Population
The study population will include patients presenting with an acute myocardial infarction NSTEMI or STEMI undergoing cardiac catheterization at the Foothills Medical Center who have significant left ventricular impairment upon initial LV assessment as defined as at least
At least mod dysfunction LVEF 040 if no prior history of MIs ie first MI
More than mild-moderate dysfunction LVEF 045 if prior history of MI Exclusion criteria include patients lost to follow up by their family physician or primary cardiologist and patients who are deceased who do not have a follow-up EF
Patients will be identified using the APPROACH Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease wwwapproachorg database All patients will have provided written informed consent as part of their participation in APPROACH
AMIQA Phase I Quality Assurance
Part One Quality Assurance will include patients with an MI occurring between July 1 2010 to November 30 2011 15 months The list of patients who have had myocardial infarctions undergoing cardiac catheterization at the Foothills Medical Center between these dates can be obtained through the APPROACH database For the patients that meet the initial inclusion criteria for significant LV dysfunction post-MI the study group will determine if a follow up LVEF assessment has been performed within 2 to 12 months post-MI by contacting the patients family physician andor primary cardiologist for any records of LVEF measurements and searching through the following electronic databases
AMIQA Phase II Prognostic Factor Study
Part Two Prognostic Factor Study will include patients with myocardial infarctions occurring on December 5 2011 until December 5 2012 12 months The list of patients who have had myocardial infarctions undergoing cardiac catheterization at the Foothills Medical Center between these dates can be obtained through the APPROACH database For the patients that meet the initial inclusion criteria for significant LV dysfunction post-MI as described in section 51 the study group will contact the patient the patients family physician andor patients primary cardiologist to order a follow up LVEF measurement within 2 to 12 months post- myocardial infarction That is all patients that have significant LV dysfunction will undergo follow up LVEF measurements between December 5 2011 and December 5 2012 Modalities for follow up LVEF measurements will include echocardiogram cardiac MRI and nuclear perfusion imaging at the discretion of the family physician or primary cardiologist
These follow up LVEF measurements will be entered into the APPROACH database in order to allow us to evaluate the clinical significance of changes in EF after MI and prognostic significance of initial versus follow-up EF values
Data Analysis
AMIQA Phase I Quality Assurance
Data collected will be entered into a database and summary statistics will be created eg proportion of follow up LVEF assessments completed post-MI Aim 51 choice of modality for follow up LVEF assessment etc Data collected from the surveys will be entered into a database and analyzed in SAS or Stata Summary statistics will be created from the data collected in the surveys
Acute Myocardial Infarction Quality Assurance AMIQA Project Research Protocol - Updated Feb 29 2012
AMIQA Phase II Prognostic Factor Study
As part of AMIQA Phase II LVEF assessments will be entered into the APPROACH database The study will compare initial LVEF measurements post-MI to follow-up LVEF measurements and assess for improvement stability and deterioration of LVEF and the factors associated with these changes in LVEF
This project has received ethics approval by the Conjoint Health Research and Ethics Board of the University of Calgary Patients will be identified using the APPROACH database have provided written informed consent as part of their participation in APPROACH Only the research team will know the names and contact information of the patients included in the study and this information will be kept confidential
Patients suffering a myocardial infraction MI may have from minimal to extensive myocardial damage While severe left ventricular LV dysfunction that persists beyond the initial 2-3 months of an MI is a predictor of sudden death the prognostic significance of less severe LV dysfunction after MI is unclear
There is significant clinical value in quantifying LV function after the recovery phase of an MI This information is vital in guiding the breadth and duration of therapies known to improve prognosis beta-blockers ACE inhibitors angiotensin blockers anticoagulants and others Further it will identify patients in whom other therapies such as an implantable cardioverter defibrillator ICD are recommended Yet no guidelines to guide clinical decision making in terms of collecting follow-up ejection fraction EF data in such patients who do not also have overt heart failure
Purpose The Acute Myocardial Infarction Quality Assurance AMIQA project proposes to
1 document clinical practice by collecting data on the proportion of patients with initial LV dysfunction after MI without a follow-up EF assessment arranged
2 collect follow-up EF data in patients with initial LV dysfunction post-MI and evaluate the prognostic significant of EF early and late after MI as well as factors associated with the change in value and
3 educate physicians regarding the importance of EF reassessment after MI
Follow up LV assessment
The current guidelines do not clearly provide clear indications to the appropriate timing or modality of follow up left ventricular assessments We have chosen to define an adequate follow up LV assessment to occur within 2 to 12 months post-myocardial infarction measured by any modality such as echocardiography cardiac MRI or nuclear perfusion scan
Overall Study Objectives
1 To evaluate the relationship of changes in EF after MI with clinical variables such as age gender co-morbid conditions MI characteristics and the prescription of pharmacological agents after MI
2 To assess the relationship of changes in EF after MI with clinical outcomes
Study Methodology and Data Collection
This study will be conducted in three phases
1 determining the existing practice of assessing left ventricular ejection fraction following myocardial infarction within the Calgary region Quality Assurance
2 determining the factors associated with LVEF improvement stability and decline post-MI and the relationship of these with outcome Prognostic Factor Study
3 educating the clinical community about the importance of follow up LVEF assessments and reporting the findings of this through presentations educational materials andor academic publications Knowledge Dissemination
Study Population
The study population will include patients presenting with an acute myocardial infarction NSTEMI or STEMI undergoing cardiac catheterization at the Foothills Medical Center who have significant left ventricular impairment upon initial LV assessment as defined as at least
At least mod dysfunction LVEF 040 if no prior history of MIs ie first MI
More than mild-moderate dysfunction LVEF 045 if prior history of MI Exclusion criteria include patients lost to follow up by their family physician or primary cardiologist and patients who are deceased who do not have a follow-up EF
Patients will be identified using the APPROACH Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease wwwapproachorg database All patients will have provided written informed consent as part of their participation in APPROACH
AMIQA Phase I Quality Assurance
Part One Quality Assurance will include patients with an MI occurring between July 1 2010 to November 30 2011 15 months The list of patients who have had myocardial infarctions undergoing cardiac catheterization at the Foothills Medical Center between these dates can be obtained through the APPROACH database For the patients that meet the initial inclusion criteria for significant LV dysfunction post-MI the study group will determine if a follow up LVEF assessment has been performed within 2 to 12 months post-MI by contacting the patients family physician andor primary cardiologist for any records of LVEF measurements and searching through the following electronic databases
AMIQA Phase II Prognostic Factor Study
Part Two Prognostic Factor Study will include patients with myocardial infarctions occurring on December 5 2011 until December 5 2012 12 months The list of patients who have had myocardial infarctions undergoing cardiac catheterization at the Foothills Medical Center between these dates can be obtained through the APPROACH database For the patients that meet the initial inclusion criteria for significant LV dysfunction post-MI as described in section 51 the study group will contact the patient the patients family physician andor patients primary cardiologist to order a follow up LVEF measurement within 2 to 12 months post- myocardial infarction That is all patients that have significant LV dysfunction will undergo follow up LVEF measurements between December 5 2011 and December 5 2012 Modalities for follow up LVEF measurements will include echocardiogram cardiac MRI and nuclear perfusion imaging at the discretion of the family physician or primary cardiologist
These follow up LVEF measurements will be entered into the APPROACH database in order to allow us to evaluate the clinical significance of changes in EF after MI and prognostic significance of initial versus follow-up EF values
Data Analysis
AMIQA Phase I Quality Assurance
Data collected will be entered into a database and summary statistics will be created eg proportion of follow up LVEF assessments completed post-MI Aim 51 choice of modality for follow up LVEF assessment etc Data collected from the surveys will be entered into a database and analyzed in SAS or Stata Summary statistics will be created from the data collected in the surveys
Acute Myocardial Infarction Quality Assurance AMIQA Project Research Protocol - Updated Feb 29 2012
AMIQA Phase II Prognostic Factor Study
As part of AMIQA Phase II LVEF assessments will be entered into the APPROACH database The study will compare initial LVEF measurements post-MI to follow-up LVEF measurements and assess for improvement stability and deterioration of LVEF and the factors associated with these changes in LVEF
This project has received ethics approval by the Conjoint Health Research and Ethics Board of the University of Calgary Patients will be identified using the APPROACH database have provided written informed consent as part of their participation in APPROACH Only the research team will know the names and contact information of the patients included in the study and this information will be kept confidential
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None