Influence Of Incomplete Revascularization on Long-Term Outcomes After Primary Percutaneous Coronary Intervention (PPCI)

Primary Percutaneous Coronary Intervention Clinical Trial

Official title:

Influence Of Incomplete Revascularization on Long-Term Outcomes After Primary Percutaneous Coronary Intervention (PPCI). A Single Center Real-Life Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332250
• Other study ID #: Amany Edward Ramzy
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

• Study groups: Patients will be divided into 2 groups

1. Group I: Complete revascularization was achieved by PPCI.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3200
• Est. completion date: December 30, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

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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

Related Conditions & MeSH terms

• Primary Percutaneous Coronary Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amany Edward Ramzy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mace	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