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A study to evaluate the clinical performance of the Bisoprolol in post myocardial infarction patients

To Evaluate the â??Real Worldâ?? CliNicalPerformAnce of the Bisoprolol in Post-myoCardial InfarcTion with Left Ventricular dYsfunction - TENACITY

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/05/025009
Enrollment
400
Registered
2020-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I252- Old myocardial infarction

Interventions

Intervention1: NIL: NIL

Sponsors

Dr Kamal Sharma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Post MI (NSTEMI & STEMI) patients with systolic LV dysfunction (HFmEF&HFrEF i.e. LVEF Patients prescribed with oral Bisoprolol (Concor) during or on discharge from the index hospitalization between 1st August 2016 to 30th November 2018 and follow-up data for up to 1 year from date of discharge and initiation of treatment under consideration, is available Consent for data collection

Exclusion criteria

Exclusion criteria: Age Patients with Beta Blocker other than bisoprolol at the index date Patients who leave against medical advice during the hospitalization for MIwith incomplete revascularization. Patients who die during hospitalization for MI Patients presenting with high grade II degree and III degree AV block at the index date (contra-indication to beta-blockers)

Design outcomes

Primary

MeasureTime frame
Measure mean changes in heart rate from baseline at the time of index event of hospitalization and at 1 year duration follow-upTimepoint: Baseline and 12 months

Secondary

MeasureTime frame
- Percentage of patients with dyslipidemia by serum lipids after achieving steady dosing with Bisoprolol treatment and during 1-year follow-up, as compared to baseline at the index hospitalization, as recorded in clinical notes, usually performed once at baseline, at 6 months and again at 1-year.Timepoint: 6, 12 months;- Percentage of patients with glycaemic control by blood sugar (fasting and post prandial) and glycosylated haemoglobin (HbA1c) after achieving steady dosing with Bisoprolol treatment and during 1-year follow-up, as compared to baseline at the index hospitalization, as recorded in clinical notes, usually performed once at baseline, at 6 months and again at 1-year.Timepoint: 3,6,9 and 12 months;- Recorded changes in heart rate during past patient visits, usually planned every 3 months, during the treatment, until 1 year follow-up and itâ??s correlation if any with other secondary end pointsTimepoint: 3,6,9 and 12 months;- Recorded changes in LVEF Echocardiographically during the course of 1 year treatment and follow-up, usually performed once at baseline, at 6 months and again at 1-year.Timepoint: 3,6,9 and 12 months;- Recorded ST Segment changes on EKG from J point during the treatment course and at time of discharge/ completion of 1 year follow up as compared to baseline at the index hospitalization discharge EKG.Timepoint: 12 months

Countries

India

Contacts

Public ContactMr Nimesh Parekh

Sanjivani Super Speciality Hospital

kamalsharma1975@gmaol.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026