- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04332250
Influence Of Incomplete Revascularization on Long-Term Outcomes After Primary Percutaneous Coronary Intervention (PPCI)
April 1, 2020 updated by: Amany Edward Ramzy
Influence Of Incomplete Revascularization on Long-Term Outcomes After Primary Percutaneous Coronary Intervention (PPCI). A Single Center Real-Life Retrospective Analysis
evaluate the influence of incomplete revascularization during the index hospitalization on in-hospital and long-term outcomes in STEMI patients undergoing PPCI in Assiut University heart hospital.
Study Overview
Status
Completed
Conditions
Detailed Description
Study groups: Patients will be divided into 2 groups
- Group I: Complete revascularization was achieved by PPCI.
- Group II: Complete revascularization was not achieved by PPCI.
- In hospital outcomes: All the patients will be reviewed for during hospital admission to record major acute cardiac events (MACE). Only the most serious event of major adverse cardiac events will be used to calculate the cumulative major adverse cardiac events per patient according to the following sequence: (death > heart failure > recurrent non-fatal MI > serious secondary arrhythmia necessitating DC shock> recurrent or refractory angina. MACE will be reported according to the standard definitions.(Tsai IT, et al.,2017)
- Long-term follow-up: The patients will be followed by telephone interviews for all-cause mortality, re-hospitalization by ACS, re-hospitalization by heart failure, planned and unplanned PCI or CABG. Long-term MACE will include: all-cause mortality, re-hospitalization by ACS, re-hospitalization by heart failure, unplanned revascularization. Patients who undergo planned revascularization later on after discharge will be followed till the date of revascularization for actual events and will be censored in Kaplan Meier Survival analysis. These patients will be included in a third group of staged late complete revascularization to be followed for the long-term MACE events starting from the planned revascularization procedure.
Study Type
Observational
Enrollment (Actual)
3200
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All Patients aged >18 years with STEMI admitted to Assiut University Heart hospital and underwent successful PPCI between January 2016 to December 2019 were recruited.
Selection of patients for primary PCI was as per guideline recommendations
Description
Inclusion Criteria:
All Patients aged >18 years with STEMI admitted to Assiut University Heart hospital and underwent successful PPCI between January 2016 to December 2019 were recruited. Selection of patients for primary PCI was as per guideline recommendations.
-
Exclusion Criteria:
- Patients with incomplete data.
- Patients with previous coronary artery bypass grafting (CABG).
- Patients presenting with cardiogenic shock, cardiac arrest or pulmonary edema.
- Mechanical complications of MI; namely VSD, wall rupture, mitral regurgitation secondary to papillary muscle or chordal rupture.
- Patients with unsuccessful PPCI with a final TIMI flow ≤ I in infarct related artery.
- Patients with a significant co-morbidity reducing life expectancy to <1 year as patients with advanced liver diseases, cerebrovascular diseases, malignancy and chronic lung diseases that could affect patient prognosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mace
Time Frame: between January 2016 to December 2019 were recruited
|
All the patients will be reviewed for during hospital admission to record major acute cardiac events (MACE).
Only the most serious event of major adverse cardiac events will be used to calculate the cumulative major adverse cardiac events per patient according to the following sequence: (death > heart failure > recurrent non-fatal MI > serious secondary arrhythmia necessitating DC shock> recurrent or refractory angina.
MACE will be reported according to the standard definitions
|
between January 2016 to December 2019 were recruited
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 30, 2019
Study Registration Dates
First Submitted
March 31, 2020
First Submitted That Met QC Criteria
March 31, 2020
First Posted (Actual)
April 2, 2020
Study Record Updates
Last Update Posted (Actual)
April 3, 2020
Last Update Submitted That Met QC Criteria
April 1, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Amany Edward Ramzy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Percutaneous Coronary Intervention
-
Sheffield Teaching Hospitals NHS Foundation TrustCompletedPrimary Percutaneous Coronary InterventionUnited Kingdom
-
Ospedale della MisericordiaUnknownTo Achieve an Early Reendothelialization at the Expense of Low Restenosis: The EREMUS Study (EREMUS)Percutaneous Coronary Intervention | Angioplasty, Transluminal, Percutaneous CoronaryItaly
-
Asan Medical CenterLN RoboticsRecruitingPercutaneous Coronary InterventionKorea, Republic of
-
Portola PharmaceuticalsCompletedPercutaneous Coronary InterventionUnited States, Austria, Canada, Germany, Poland
-
Shiraz University of Medical SciencesBaqiyatallah university of medical sciencesCompletedPercutaneous Coronary Intervention
-
Corindus Inc.Completed
-
University of GroningenAbbottUnknownPercutaneous Coronary InterventionNetherlands
-
Stiftung Institut fuer HerzinfarktforschungCompletedPercutaneous Coronary InterventionGermany
-
Beijing Anzhen HospitalUnknownPercutaneous Coronary InterventionChina
-
SanofiCompletedPercutaneous Coronary Intervention