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Completed

NCT Number: NCT02932696

Post Infarction Exercise Effects on Myocardial Function Assessed by 2D Strain Ultrasound

The main goal of our project is to study and describe the effect of exercise training on systolic and diastolic myocardial function assessed by 2D ultrasound strain after myocardial infarction.

Our working hypothesis is that the intrinsic myocardial contractility and relaxation assessed by global longitudinal strain in phase II (or 2D strain) during post-infarction exercise training will be improved compared to baseline values as well as compared to values in a no-training group. Should this hypothesis prove true, it would help explain the improvements in functional capacity observed during the post-infarction period and after exercise training.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 4 months of follow-up
  • The patient had a first myocardial infarction episode (within the past 3 months) requiring medical treatment or revascularisation (e.g. balloon angioplasty) or aortocoronary bypass

Exclusion criteria

  • The patient is simultaneously participating in (or has participated in the past 3 months) another interventional study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection or under guardianship
  • It is impossible to correctly inform the patient or the patient refuses to sign the consent
  • The patient is pregnant, parturient, or breastfeeding
  • Contra indication for exercise training
  • Valve prosthesis
  • Severe valvular disease
  • Pacemaker
  • Heart transplant
  • Non sinus rhythm

Treatment and study plan

Cardiac training program

Other

This program takes place at the Cardiovascular Rehabilitation Department at the Nîmes University Hospital and includes a combination of various physical activities: treadmill, exercise bike, rower, aerobics, gymnastics, serious games, swimming. The program begins approximately within 3 months after myocardial infarction and consists of 20 consecutive days of training. The main physical activity is aerobic interval training (AIT).

30-minute AIT sessions will occur 5x per week for 4 weeks.

1 AIT session includes a warm up for 8 minutes to reach a heart rate during exercise corresponding to 20 to 30% of maximum aerobic power determined during the initial effort test. Then interval training occurs with 4x2 min of high intensity effort (heart rate during exercise corresponding to 80% of maximum aerobic power) alternating with 2 min of active recovery at 20-30% of maximum aerobic power. Then recovery for 8 minutes.

Primary outcomes

  1. The % global longitudinal strain of the left ventricle

    Time frame: within 3 months post infarction = T0 (baseline)

  2. The % global longitudinal strain of the left ventricle

    Time frame: 5 weeks

  3. The % global longitudinal strain of the left ventricle

    Time frame: 3 months

Secondary outcomes

  1. maximal oxygen consumption (VO2max; mL/min/kg)

    Time frame: within 3 months post infarction = T0 (baseline)

  2. maximal oxygen consumption (VO2max; mL/min/kg)

    Time frame: T0 + 5 weeks

  3. maximal oxygen consumption (VO2max; mL/min/kg)

    Time frame: T0 + 3 months

  4. maximum aerobic power (watts)

    Time frame: within 3 months post infarction = T0 (baseline)

  5. maximum aerobic power (watts)

    Time frame: T0 + 5 weeks

  6. maximum aerobic power (watts)

    Time frame: T0 + 3 months

  7. First ventilatory threshold (mL/min/kg)

    Time frame: within 3 months post infarction = T0 (baseline)

  8. First ventilatory threshold (mL/min/kg)

    Time frame: T0 + 5 weeks

  9. First ventilatory threshold (mL/min/kg)

    Time frame: T0 + 3 months

  10. left ventricle longitudinal systolic strain rate

    Time frame: within 3 months post infarction = T0 (baseline)

  11. left ventricle longitudinal systolic strain rate

    Time frame: T0 + 5 weeks

  12. left ventricle longitudinal systolic strain rate

    Time frame: T0 + 3 months

  13. left ventricle longitudinal diastolic strain rate

    Time frame: within 3 months post infarction = T0 (baseline)

  14. left ventricle longitudinal diastolic strain rate

    Time frame: T0 + 5 weeks

  15. left ventricle longitudinal diastolic strain rate

    Time frame: T0 + 3 months

  16. % radial systolic strain

    Time frame: within 3 months post infarction = T0 (baseline)

  17. % radial systolic strain

    Time frame: T0 + 5 weeks

  18. % radial systolic strain

    Time frame: T0 + 3 months

  19. % radial diastolic strain

    Time frame: within 3 months post infarction = T0 (baseline)

  20. % radial diastolic strain

    Time frame: T0 + 5 weeks

  21. % radial diastolic strain

    Time frame: T0 + 3 months

  22. % circumferential systolic strain

    Time frame: within 3 months post infarction = T0 (baseline)

  23. % circumferential systolic strain

    Time frame: T0 + 5 weeks

  24. % circumferential systolic strain

    Time frame: T0 + 3 months

  25. % circumferential diastolic strain

    Time frame: within 3 months post infarction = T0 (baseline)

  26. % circumferential diastolic strain

    Time frame: T0 + 5 weeks

  27. % circumferential diastolic strain

    Time frame: T0 + 3 months

  28. Radial systolic strain rate

    Time frame: within 3 months post infarction = T0 (baseline)

  29. Radial systolic strain rate

    Time frame: T0 + 5 weeks

  30. Radial systolic strain rate

    Time frame: T0 + 3 months

  31. Radial diastolic strain rate

    Time frame: within 3 months post infarction = T0 (baseline)

  32. Radial diastolic strain rate

    Time frame: T0 + 5 weeks

  33. Radial diastolic strain rate

    Time frame: T0 + 3 months

  34. Circumferential systolic strain rate

    Time frame: within 3 months post infarction = T0 (baseline)

  35. Circumferential systolic strain rate

    Time frame: T0 + 5 weeks

  36. Circumferential systolic strain rate

    Time frame: T0 + 3 months

  37. Circumferential diastolic strain rate

    Time frame: within 3 months post infarction = T0 (baseline)

  38. Circumferential diastolic strain rate

    Time frame: T0 + 5 weeks

  39. Circumferential diastolic strain rate

    Time frame: T0 + 3 months

  40. Telediastolic volume (mL)

    Time frame: within 3 months post infarction = T0 (baseline)

  41. Telesystolic volume (mL)

    Time frame: T0 + 5 weeks

  42. Telesystolic volume (mL)

    Time frame: T0 + 3 months

  43. Telediastolic volume (mL)

    Time frame: T0 + 5 weeks

  44. Telediastolic volume (mL)

    Time frame: T0 + 3 months

  45. Left ventricle mass (g/m^2)

    Time frame: within 3 months post infarction = T0 (baseline)

  46. Left ventricle mass (g/m^2)

    Time frame: T0 + 5 weeks

  47. Left ventricle mass (g/m^2)

    Time frame: T0 + 3 months

  48. Ejection fraction of the left ventricle

    Time frame: within 3 months post infarction = T0 (baseline)

  49. Ejection fraction of the left ventricle

    Time frame: T0 + 5 weeks

  50. Ejection fraction of the left ventricle

    Time frame: T0 + 3 months

  51. S' wave velocity (cm/s)

    Time frame: within 3 months post infarction = T0 (baseline)

  52. S' wave velocity (cm/s)

    Time frame: T0 + 5 weeks

  53. S' wave velocity (cm/s)

    Time frame: T0 + 3 months

  54. E' wave velocity (cm/s)

    Time frame: within 3 months post infarction = T0 (baseline)

  55. E' wave velocity (cm/s)

    Time frame: T0 + 5 weeks

  56. E' wave velocity (cm/s)

    Time frame: T0 + 3 months

  57. A' wave velocity (cm/s)

    Time frame: within 3 months post infarction = T0 (baseline)

  58. A' wave velocity (cm/s)

    Time frame: T0 + 5 weeks

  59. A' wave velocity (cm/s)

    Time frame: T0 + 3 months

  60. The E/A ratio

    Time frame: within 3 months post infarction = T0 (baseline)

  61. The E/A ratio

    Time frame: T0 + 5 weeks

  62. The E/A ratio

    Time frame: T0 + 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Post Infarction Exercise Training Effects on Systolic and Diastolic Myocardial Function Assessed by 2D Strain Ultrasound

Acronym: TrainStrain

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 13, 2016
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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