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CTRI Number  CTRI/2024/07/070833 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 17/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparison of outcome in hospital in patients of myocardial infarction undergoing primary angioplasty having total occlusion vs critical stenosis in other arteries. 
Scientific Title of Study   Comparison of In-hospital outcome in patients of ST-segment elevation myocardial infarction undergoing primary angioplasty with chronic total occlusion Vs severe stenosis in non-culprit arteries  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANKUSHA PATRA 
Designation  SENIOR RESIDENT 
Affiliation  ABVIMS and DR RML HOSPITAL 
Address  ABVIMS and DR RML HOSPITAL, BABA KHARAK SINGH MARG, NEW DELHI

New Delhi
DELHI
110001
India 
Phone  8223827356  
Fax    
Email  ankushapatro002@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bhagya Narayan Pandit 
Designation  Professor 
Affiliation  ABVIMS and DR RML Hospital 
Address  ABVIMS and Dr RML Hospital, Baba kharak singh marg, New delhi.
Baba Kharak Singh Marg, New delhi.
New Delhi
DELHI
110001
India 
Phone  9350188470  
Fax    
Email  bnpandit1977@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bhagya Narayan Pandit 
Designation  Professor 
Affiliation  ABVIMS and DR RML Hospital 
Address  ABVIMS and Dr RML Hospital, Baba kharak singh marg, New delhi.
Baba Kharak Singh Marg, New delhi.

DELHI
110001
India 
Phone  9350188470  
Fax    
Email  bnpandit1977@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr RML Hospital, Baba kharak singh marg, New delhi, India, Pin code-110001 
 
Primary Sponsor  
Name  ABVIMS and Dr RML Hospital 
Address  ABVIMS and Dr RML Hospital, Baba kharak singh marg, New delhi, India, Pin code-110001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr ANKUSHA PATRA  ABVIMS AND DR RML HOSPITAL  Departrment of cardiology, Dr. RML hospital, Baba Kharak Singh Marg, New Delhi. pin code - 110001
New Delhi
DELHI 
8223827356

ankushapatro002@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, ABVIMS, Dr. RML Hospital ABVIMS, Dr Ram Manohar Lohia Hospital, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients with Acute STEMI undergoing primary angioplasty in window period and having severe stenosis (≥90 %) in non culprit arteries after written informed consent. 
 
ExclusionCriteria 
Details  1. Known case of myeloproliferative disorders and hematological malignancy.
2. Acute infection, tuberculosis, Sepsis
3. Pregnancy
4. Patients with severe valvular heart disease (excluding secondary cause)
5. Patients with congenital heart disease.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of In-hospital mortality, cardiogenic shock, heart failure and arrhythmia in acute ST-segment elevation myocardial infarction patients undergoing primary angioplasty with chronic total occlusion Vs severe stenosis in non-culprit arteries  At the time of discharge 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Coronary artery disease (CAD) continues to be the foremost cause of cardiac mortality and morbidity, and causes a negative impact on the physical, psychological, social, and occupational functioning of patients. CAD affects around 126 million individuals (1,655 per 100,000), which is approximately 1.72% of the world’s population and around nine million deaths are caused by CAD globally. The global prevalence of CAD is rising. There are several factors associated with poor clinical outcomes in AMI, one important factor being chronic total occlusion (CTO) in non-infarct related artery (IRA). Coronary chronic total occlusions(CTOs) is defined as occluded coronary segment with thrombolysis in myocardial infarction (TIMI) flow 0 for ≥ 3 months duration. Approximately 18–33% of patients with significant coronary disease on coronary angiography have atleast one CTO.
Recent studies have shown that the predictive significance of Multi-vessel disease is primarily influenced by the existence of a chronic total occlusion (CTO) in a non-infarct-related artery (IRA). Chronic total occlusion (CTO) is associated with both cardiogenic shock upon admission and early mortality. The HORIZONS-AMI trial found that among patients with ST-elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI), having multi-vessel disease (MVD) with a chronic total occlusion (CTO) in a non-infarct-related artery (IRA) is linked to worsened markers of reperfusion and higher mortality. In STEMI patients complicated by cardiogenic shock, CTO in non-IRA is associated with increased mortality.  A large retrospective study showed that the MACE, all-caused death and cardiac death is significantly higher in patients of CTO vs 90-99%  stenosis.

Presence of CTO in non-culprit artery is also associated with poor left ventricular ejection fraction (LVEF) and further deterioration of LVEF in follow-up. In patients of STEMI, a cardiac magnetic resonance study revealed that the existence of CTO increases myocardial injury and rates of major adverse cardiovascular events (MACE). In one trial, it had been showed that revascularisation for CTO with reduced EF would be associated with better prognosis than optimal medical therapy. Whereas the EXPLORE trial, which conducted a random assignment of STEMI patients with CTO into groups undergoing percutaneous coronary intervention (PCI) to CTO and those without PCI to CTO, did not observe a general advantage for PCI to CTO concerning left ventricular ejection fraction (LVEF) or left ventricular end-diastolic volume (LVEDV).  However, the success rate of PCI to CTO was not sufficiently high in this trial. However, these studies defined multi-vessel disease as lesions with a diameter stenosis of ≥50%. These studies included patients with single-vessel disease or intermediate stenosis as competitors to the CTO group.

Upto now most of the studies compared CTO to non-CTO and did not see the in-hospital outcome of non-culprit CTO to severe stenosis in non-IRA, therefore in this study we probe to see the in-hospital outcome of CTO vs severe stenosis in non-IRA to further prove the role of CTO itself  in patients of acute STEMI undergoing primary PCI

 
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