Effect of Exercise on Platelet Reactivity After Myocardial Infarction

NCT02958657 | Completed

• 1 other identifier: 12163
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to evaluate, in recent post-acute myocardial infarction (AMI) patients on dual antiplatelet therapy, the impact of regular exercise training on platelet aggregability and the correlation between the level of platelet aggregability and muscle sympathetic nerve activity (MSNA).

Conditions

Platelet Aggregation; Acute Myocardial Infarction; Exercise Training

Keywords

Platelet function; Autonomic Nervous System; Multiplate® (Multiple Electrode Aggregometry - MEA); VerifyNow®

Outcome Measures

Primary Outcomes (1)

• Platelet aggregability by VerifyNow-P2Y12®

  To measure in recent post-AMI patients on dual antiplatelet therapy the impact of 03 months of regular exercise training (starting 30 days after the AMI) on platelet aggregability, analyzed by VerifyNow-P2Y12® test.

  Before the second CPET (04 months pot-AMI)

Secondary Outcomes (5)

• Platelet aggregability by Multiplate-ADP®

  After the first CPET (01 month post-AMI)

• Platelet aggregability by Multiplate-ASPI®

  After the first CPET (01 month post-AMI)

• Platelet aggregability by Multiplate-ADP®

  After the second CPET (04 months post-AMI)

• Platelet aggregability by Multiplate-ASPI®

  After the second CPET (04 months post-AMI)

• Sympathetic activity by MSNA

  Before the second CPET (04 months post-AMI)

Study Arms (2)

Exercise Training

EXPERIMENTAL

Patients randomized to the training group will start the supervised regular training program 01 month after the myocardial infarction, and it will last for three months.

Other: Exercise Training

Control Group

NO INTERVENTION

Patients in the control group will receive general instructions regarding rehabilitation post-acute myocardial infarction and will be followed for four months after the myocardial infarction.

Interventions

Exercise Training OTHER

Supervised exercise training program that includes two workouts per week for three months at a rehabilitation unit.

Also known as: Physical Activity, Physical Training, Rehabilitation

Exercise Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization for spontaneous STEMI or non-STEMI in patients older than 18 years.

You may not qualify if:

• Any condition that contraindicate physical activity;
• Regular exercise training practitioners prior to the ischemic event;
• Planned revascularization in the following 4 months;
• Hospitalization for cardiovascular events in the previous 12 months;
• Ventricular dysfunction, defined as left ventricular ejection fraction (LVEF) \<45% on echocardiography, evaluated by Simpson's method);f) Killip class III and IV;
• High risk of arrhythmia and/or second and third degree atrioventricular block;
• Diabetes mellitus requiring intravenous insulin therapy during hospitalization;
• Important chronic kidney disease, defined by creatinine clearance\<30ml/min/m2 (estimated by MDRD formula);
• Oral anticoagulation;
• Use of NSAIDs and/or dipyridamole;
• Contraindication to dual antiplatelet therapy;
• Serum hemoglobin level \<10 g/dL;
• Use of glycoprotein IIB/IIIA inhibitors in the last 48 hours;
• Terminal illness;
• Liver disease or coagulopathy;

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Heart Institute of University of Sao Paulo Medical School

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (1)

• Dalcoquio TF, Alves Dos Santos M, Silva Alves L, Bittar Brito Arantes F, Ferreira-Santos L, Pinto Brandao Rondon MU, Furtado RHM, Gehlen Ferrari A, Genestreti Rizzo PR, Salsoso R, Franci A, Moreira Baracioli L, de Nazare Nunes Alves MJ, Negrao CE, Nicolau JC. Effects of exercise on platelet reactivity after myocardial infarction: a randomized clinical trial. Platelets. 2023 Dec;34(1):2139821. doi: 10.1080/09537104.2022.2139821. Epub 2022 Nov 14.

  PMID: 36377063 DERIVED

MeSH Terms

Interventions

Exercise; Physical Conditioning, Human; Rehabilitation

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Talia F Dalçóquio, MD

  Heart Institute (InCor) University of Sao Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: November 8, 2016
• Study Start: October 30, 2016
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)