- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02356510
Which One Should be Treated in the Setting of Acute ST Elevation Myocardial Infarction - Culprit Lesion or Culprit Vessel?
Study Overview
Detailed Description
Patient selection: This multi-centre retrospective study included patients from 3 high-volume primary PCI centres in Turkey. A total number of 5512 patients underwent emergent PCI for acute STEMI between January 2011 and December 2013. From this patient population, patients were looked for the presence of an additional lesion to the culprit lesion (CL). Additional lesion was defined as the presence of an angiographically severe (≥70%) lesion other than the CL either proximal or distal to it in the same coronary artery after the distal flow was observed most commonly as a result of guide-wire passage or PTCA of the total occlusion.
Exclusion criteria: - Presence of LMCA lesion
- Cardiogenic shock
- Previous CABG operation
- Decision for CABG operation after primary PCI
- Severe valvular disease including aortic stenosis of mitral insufficiency
- Severe kidney disease (serum creatinine >2.5 mg/dl or patients on maintenance hemodialysis)
- Rejection of second PCI by the patient after the index event
The eligible patients were retrospectively sought from the database of the relevant hospital. The basal characteristics of the patients like age, sex, presence of coronary risk factors (smoking, hypertension, diabetes mellitus and hyperlipidemia), vital signs and location of STEMI at admission were noted. The emergent coronary angiograms of the patients were then examined and several angiographic and post-PCI features which are defined in detail in the following sections were addressed. Follow-up of these patients were succeeded either by phone call, routine polyclinic visits or from the database of hospital.
Study groups: Patients were grouped into 2 according to the PCI strategy; culprit vessel (CV) group including patients who underwent emergent PCI of all severe (≥70 stenosis in CAG) lesions in the culprit vessel and culprit lesion (CL) group including patients who underwent emergency PCI only for the CL and staged PCI in 2 weeks for the other additional lesions in the CV. Both groups underwent staged PCI for the severe lesion(s) in non-culprit vessel(s) if necessary in a different session in 28 days after the index event. Staged PCI was the preferred strategy in both groups if necessary because staged PCI has been found to be at least non-inferior to other strategies in several studies [3, 4, 10, 13].
Definition of acute STEMI: The criteria for diagnosis of STEMI were: (1) chest pain within 24 h before admission that lasted for more than 30 min and was not relieved by sublingual nitroglycerin; (2) ST-segment elevation on electrocardiogram; and (3) elevated serum creatine kinase (CK) or troponin levels.
Emergent coronary angiography and PCI procedure: All patients were routinely treated with heparin, clopidogrel, aspirin, statin and an angiotensin converting enzyme inhibitor or angiotensin II receptor blocker unless contraindicated.
Coronary angioplasty and stent implantation were performed according to standard percutaneous techniques through the femoral artery. Standard selective coronary angiography with at least 4 views of the left coronary system and 2 views of the right coronary artery was performed using the Judgkins technique.
All the patients with the diagnosis of acute STEMI underwent emergent PCI with bare metal or drug-eluting stents. Stent implantation was performed at an inflation pressure of 10 to 16 atm. When suboptimal stent deployment was observed, angiographic optimization was performed using high-pressure noncompliant balloon dilatation to achieve <20% residual stenosis by visual estimation. Angiographic no-reflow phenomenon was diagnosed if a significant coronary flow decrease (Thrombolysis In Myocardial Infarction [TIMI] grade <3 flow) without mechanical obstruction was noticed in final cineangiograms obtained at completion of the PCI procedure [14, 15].
Staged PCI: Staged PCI procedure was performed either to the culprit vessel in CL group and/or to the non-culprit lesion(s) in non-culprit vessel(s) in both groups in 14 days after the index event. In the CL group, it was performed to culprit and non-culprit vessels during same intervention. In the CV group, it was performed to non-culprit vessels if necessary.
Follow-up of patients: The investigators collected follow-up information from the database of the hospitals and/or during telephone calls with patients. Follow-up included screening for major outcomes including death (in-hospital, cardiac and non-cardiac), non-fatal myocardial infarction, and need for surgical or percutaneous revas¬cularisation.
Myocardial infarction was defined as a troponin level above the 99th percentile and symptoms of cardiac ischemia. For patients with re-infarction, the definition required ≥20% increase of cardiac markers (Troponin) with ischemic symptoms or ECG findings or angiographic evidence of coronary artery occlusion including early stent thrombosis. Early stent thrombosis was defined as acute myocardial infarction due to stent thrombosis in 30 days after implantation, usually during index hospitalization.
Statistical analysis: The analysis of the results was performed using the Predictive Analytics SoftWare (PASW) Statistics 18.0 for Windows (Statistical Package for the Social Sciences, SPSS Inc., Chicago, Illinois). Data were tested for a normal distribution using the Kolmogorov-Smirnov test. The categorical variables were shown as numbers of cases with percentages and the normally distributed continuous variables were shown as mean ± SD. Student's t-test was used for the analysis of the continuous variables that were normally distributed and the χ2 test for the categorical variables. The Kruskal-Wallis rank-sum test was used for the variables that were not normally distributed. Statistical significance was defined as p value less than 0.05.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who underwent primary PCI for acute STEMI and had >1 lesion in the culprit artery
Exclusion Criteria:
- Presence of LMCA lesion
- Cardiogenic shock
- Previous CABG operation
- Decision for CABG operation after primary PCI
- Severe valvular disease including aortic stenosis of mitral insufficiency
- Severe kidney disease (serum creatinine >2.5 mg/dl or patients on maintenance hemodialysis)
- Rejection of second PCI by the patient after the index event
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Culprit lesion
Patients who underwent culprit lesion only PCI during primary intervention
|
|
Culprit vessel
Patients who underwent culprit lesion only PCI during primary intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MACE
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SamsunERH
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 Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
Clinical Trials on Primary PCI
-
Minneapolis Heart Institute FoundationNational Heart, Lung, and Blood Institute (NHLBI)CompletedAcute Myocardial InfarctionUnited States
-
China-Japan Friendship HospitalRecruitingST Elevation Myocardial Infarction | Acute Coronary Syndrome | Percutaneous Coronary InterventionChina
-
Shanghai Zhongshan HospitalRecruitingST-segment Elevation Myocardial Infarction (STEMI)China
-
Jorge Sanz SanchezRecruitingST Elevation Myocardial InfarctionSpain
-
Italian Society of Invasive CardiologyMeditrial SrLCompletedAcute Myocardial InfarctionItaly
-
Qilu Hospital of Shandong UniversityCompletedMyocardial Infarction | Percutaneous Coronary Intervention | PRCPChina
-
Azienda Ospedaliero Universitaria Maggiore della...UnknownAcute Myocardial InfarctionItaly
-
Holger ThieleCompleted
-
Second Affiliated Hospital, School of Medicine,...Zhejiang University; First Affiliated Hospital of Wenzhou Medical University; Taizhou First People's Hospital and other collaboratorsAvailableST Elevation Myocardial InfarctionChina
-
Instituto Nacional de Cardiologia Ignacio ChavezCompletedMyocardial Infarction, AcuteMexico