| CTRI Number |
CTRI/2024/12/078076 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Role of SYNTAX Scores in Predicting Heart-Related Risks for Patients Undergoing Stent Placement Interventions through Angioplasty for Complex Coronary Artery Disease |
|
Scientific Title of Study
|
Predictive Risk Evaluation in Coronary Intervention and Syntax Outcomes |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Manish Juneja |
| Designation |
Head of Cardiology Department |
| Affiliation |
Rhythm Heart and Critical Care |
| Address |
3rd Floor, Plot no. 19, Opp. Ramkrishna Math, Beside Kalimata Temple, Rahate Colony Road, Dhantoli, Nagpur -12
Nagpur
MAHARASHTRA
440012
India |
| Phone |
9825973745 |
| Fax |
|
| Email |
drmanishjuneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harshawardhan Dhanraj Ramteke |
| Designation |
Head of Research Department |
| Affiliation |
Rhythm Heart and Critical Care |
| Address |
3rd Floor, Plot no. 19, Opp. Ramkrishna Math, Beside Kalimata Temple, Rahate Colony Road, Dhantoli, Nagpur -12
Nagpur
MAHARASHTRA
440012
India |
| Phone |
8369525334 |
| Fax |
|
| Email |
harshawardhanramteke7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshawardhan Dhanraj Ramteke |
| Designation |
Head of Research Department |
| Affiliation |
Rhythm Heart and Critical Care |
| Address |
3rd Floor, Plot no. 19, Opp. Ramkrishna Math, Beside Kalimata Temple, Rahate Colony Road, Dhantoli, Nagpur -12
MAHARASHTRA
440012
India |
| Phone |
8369525334 |
| Fax |
|
| Email |
harshawardhanramteke7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rhythm Heart and Critical Care, 3rd Floor, Plot, no. 19, Road, opp. Ramkrishna Math Road, beside Kalimata Temple, Rahate Colony, Dhantoli, Nagpur, Maharashtra, India 440012 |
|
|
Primary Sponsor
|
| Name |
Rhythm Heart and Critical Care |
| Address |
3rd Floor, Plot no. 19, Opp. Ramkrishna Math, Beside Kalimata Temple, Rahate Colony Road, Dhantoli, Nagpur -12 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manish Junjeja |
Rhythm Heart and Critical Care |
3rd Floor, Plot no. 19, Opp. Ramkrishna Math, Beside Kalimata Temple, Rahate Colony Road, Dhantoli, Nagpur -12
Nagpur
MAHARASHTRA |
9825973745
drmanishjuneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKCC Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: Adults aged 20 years and above.
2. Gender: Both male and female participants.
3. Echocardiographic Readings: Participants with normal echocardiographic parameters based on existing clinical records.
4. Medical History: No history of diabetes, hypertension, or any cardiac illness. No history of significant systemic diseases or malignancies.
5. Body Composition: Participants with body surface area (BSA)-indexed echocardiographic measurements within normal ranges.
6. Regional Representation: Data will be drawn from participants across various regions to ensure national representation. |
|
| ExclusionCriteria |
| Details |
1. Pre-existing Cardiac Conditions:Participants with structural heart abnormalities (e.g., congenital or acquired). Any prior diagnosis of heart disease (including ischemic heart disease, cardiomyopathies, or
valvular heart diseases).
2. Systemic Illnesses: Participants with a history of systemic diseases (e.g., autoimmune diseases, cancer) or malignancy.
3. Pregnancy and Lactation:o Pregnant and lactating mothers will be excluded due to potential physiological changes in
cardiac dimensions during these conditions.
4. Lifestyle Factors: Smokers (both current and former, if smoking has significantly affected cardiac health). Chronic alcoholics (participants with a history of heavy alcohol consumption).
5. Athletes: Athletes involved in regular intensive training will be excluded due to potential alterations in cardiac dimensions caused by athletic conditioning.
6. Abnormal Cardiac Dimensions: Participants with any deviation from normal cardiac dimensions detected through pre-existing
echocardiographic data will be excluded to maintain the integrity of the "normal" dataset.
7. Incomplete Medical Records: Participants with incomplete or missing echocardiographic data or essential clinical information
will not be included. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome:
To evaluate the predictive accuracy of the SYNTAX Score II for identifying the risk of adverse cardiovascular events, including major adverse cardiovascular events (MACE), such as death, myocardial infarction, and repeat revascularization, within a specified follow-up period.
Outcome Metrics:
MACE rate (measured as a composite endpoint).
Survival rates post-percutaneous coronary intervention (PCI).
Event-free survival rates for predefined adverse outcomes. |
One Week from beginning of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare SYNTAX Score II with other risk tools, assess long-term outcomes (mortality, revascularization), evaluate procedural success, complications, & subgroup analyses by demographics & comorbidities. |
One week after the trial begins |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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)
|
25/12/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The PRECISION Trial is an observational study aimed at evaluating the predictive value of the SYNTAX Score II for assessing cardiovascular risk in patients undergoing percutaneous coronary intervention (PCI). The study will analyze retrospective data to predict major adverse cardiovascular events (MACE), including death, myocardial infarction, and repeat revascularization. Secondary outcomes include comparisons with other risk stratification tools, procedural success, long-term prognosis, and subgroup analyses by demographics and comorbidities. The expected sample size is 700 patients, with data collected from 2021–2024. |