Role of heart intervention (e.g, heart vessel ballooning and stenting) in heart attack patients presenting late between 12-72 hours of chest pain onset
- Conditions
- Health Condition 1: I219- Acute myocardial infarction, unspecified
- Registration Number
- CTRI/2024/07/070189
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Age greater than or equals to 18 years, less than or equals to 80 years
Patients having ST-segment elevation myocardial infarction (STEMI) which is defined as at least one episode of angina or angina equivalent lasting for greater than or equals to 30 minutes and supportive ECG changes as follows –
- ST-segment elevation (measured at the J-point): in at least two contiguous leads with ST-segment elevation greater than or equals to 2.5 mm in men less than 40 years, greater than or equals to 2 mm in men less than 40years, or greater than or equals to 1.5mm in women in leads V2–V3 and/or greater than or equals to 1mm in the other leads [in the absence of left ventricular (LV) hypertrophy or left bundle branch block LBBB)].
In the presence of LBBB, presence of concordant ST elevation greater than or equals to 1 mm in greater than or equals to 1 lead/ concordant ST depression greater than or equals to 1 mm in greater than or equals to 1 lead of V1-V3/ proportionally excessive discordant STE in greater than or equals to 1 lead anywhere with less than or equals to 1 mm STE, as defined by greater than or equals to 25% of the depth of the preceding S-wave (Smith-modified Sgarbossa Criteria)
New Q-waves of greater than or equals to 0.03 sec and or 1by3 of QRS complex in greater than or equals to 2 related EKG leads.
Patient presenting greater than 12 hours, but less than 72 hours of symptom onset.
Not revascularized by either thrombolysis or PCI.
i.Clinical indications of revascularization: symptom suggestive of ongoing ischemia, hemodynamic instability (Systolic blood pressure less than 90 mmHg, unresponsive to fluids, or requiring ionotropic support), refractory angina, severe congestive heart failure and/or pulmonary edema, complete heart block, refractory arrhythmia.
ii.Patients presenting with mechanical complications of STEMI – ventricular septal rupture, ventricular free wall rupture, acute severe mitral regurgitation due to papillary muscle rupture.
iii.Other serious illnesses with poor life expectancy like – malignancy, severe pulmonary disease, severe liver disease
iv.Severe renal dysfunction with serum creatinine greater than or equals to 2 mg/dl that may increase the risk of contrast nephropathy.
v.Patient who had prior CABG and qualifying infarct-related artery has been grafted previously.
vi.Severe valvular heart disease
vii.History of allergy or anaphylaxis with contrast agents.
viii.Pregnancy
ix.Contraindication to antiplatelet therapy
x.Active bleeding or bleeding diatheses
xi.Recent trauma or major surgery (during the last month); Relevant hematologic deviations (hemoglobin less than 10 g/dL or hematocrit 34%, platelet cell count of less than 100 x 103/µL, white blood cell count less than 3 x 103/µL).
xii.Recent PCI (within the last 30 days)
xiii.Previous stroke (within the last 3 months)
xiv.Known case of hypertrophic or restrictive cardiomyopathy
xv.Inability to cooperate with protocol and long term follow up
Refusal or inability to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite endpoint of all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalizationTimepoint: Outcome will be assessed at Baseline, 4th Month, 8th Month, 12th Month, 16th Month, 20th Month and 24th Month.
- Secondary Outcome Measures
Name Time Method all-cause mortality, recurrent non-fatal MI, congestive heart failure hospitalization, Health-related quality of life, Change in left ventricular ejection fraction, A composite of the first to occur of death, recurrent MI, heart failure hospitalization, sustained ventricular arrhythmia, automatic implantable cardiac defibrillator (AICD) placement, or stroke.Timepoint: Outcome will be assessed at Baseline, 4th Month, 8th Month, 12th Month, 16th Month, 20th Month & 24th Month.