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Myocardial InfarctionTrainStrainNCT02932696

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

A study testing Cardiac training program in people with Myocardial Infarction, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Cardiac training program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteFrance
Study dates
5 May 2017to 11 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • Valve prosthesis
  • Severe valvular disease
  • Pacemaker
  • Heart transplant
  • Non sinus rhythm

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Official title: Post Infarction Exercise Training Effects on Systolic and Diastolic 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.

Being tested
Cardiac training program
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac training programOther

    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.

Study groups in NCT02932696
Study groupRoleWhat they receive
Exercise trainingExperimentalPatients in this arm were encouraged to participate in an exercise training program, and they accepted to do so. Intervention: Cardiac training program
Receives: Other: Cardiac training program
No exercise trainingNo interventionPatients in this arm were encouraged to participate in an exercise training program, and they refused to do so.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The % global longitudinal strain of the left ventricle

    Measured: within 3 months post infarction = T0 (baseline)

  2. The % global longitudinal strain of the left ventricle

    Measured: 5 weeks

  3. The % global longitudinal strain of the left ventricle

    Measured: 3 months

Secondary outcomes (62)

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

    Measured: within 3 months post infarction = T0 (baseline)

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

    Measured: T0 + 5 weeks

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

    Measured: T0 + 3 months

  4. maximum aerobic power (watts)

    Measured: within 3 months post infarction = T0 (baseline)

  5. maximum aerobic power (watts)

    Measured: T0 + 5 weeks

  6. maximum aerobic power (watts)

    Measured: T0 + 3 months

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

    Measured: within 3 months post infarction = T0 (baseline)

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

    Measured: T0 + 5 weeks

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

    Measured: T0 + 3 months

  10. left ventricle longitudinal systolic strain rate

    Measured: within 3 months post infarction = T0 (baseline)

  11. left ventricle longitudinal systolic strain rate

    Measured: T0 + 5 weeks

  12. left ventricle longitudinal systolic strain rate

    Measured: T0 + 3 months

  13. left ventricle longitudinal diastolic strain rate

    Measured: within 3 months post infarction = T0 (baseline)

  14. left ventricle longitudinal diastolic strain rate

    Measured: T0 + 5 weeks

  15. left ventricle longitudinal diastolic strain rate

    Measured: T0 + 3 months

  16. % radial systolic strain

    Measured: within 3 months post infarction = T0 (baseline)

  17. % radial systolic strain

    Measured: T0 + 5 weeks

  18. % radial systolic strain

    Measured: T0 + 3 months

  19. % radial diastolic strain

    Measured: within 3 months post infarction = T0 (baseline)

  20. % radial diastolic strain

    Measured: T0 + 5 weeks

  21. % radial diastolic strain

    Measured: T0 + 3 months

  22. % circumferential systolic strain

    Measured: within 3 months post infarction = T0 (baseline)

  23. % circumferential systolic strain

    Measured: T0 + 5 weeks

  24. % circumferential systolic strain

    Measured: T0 + 3 months

  25. % circumferential diastolic strain

    Measured: within 3 months post infarction = T0 (baseline)

  26. % circumferential diastolic strain

    Measured: T0 + 5 weeks

  27. % circumferential diastolic strain

    Measured: T0 + 3 months

  28. Radial systolic strain rate

    Measured: within 3 months post infarction = T0 (baseline)

  29. Radial systolic strain rate

    Measured: T0 + 5 weeks

  30. Radial systolic strain rate

    Measured: T0 + 3 months

  31. Radial diastolic strain rate

    Measured: within 3 months post infarction = T0 (baseline)

  32. Radial diastolic strain rate

    Measured: T0 + 5 weeks

  33. Radial diastolic strain rate

    Measured: T0 + 3 months

  34. Circumferential systolic strain rate

    Measured: within 3 months post infarction = T0 (baseline)

  35. Circumferential systolic strain rate

    Measured: T0 + 5 weeks

  36. Circumferential systolic strain rate

    Measured: T0 + 3 months

  37. Circumferential diastolic strain rate

    Measured: within 3 months post infarction = T0 (baseline)

  38. Circumferential diastolic strain rate

    Measured: T0 + 5 weeks

  39. Circumferential diastolic strain rate

    Measured: T0 + 3 months

  40. Telediastolic volume (mL)

    Measured: within 3 months post infarction = T0 (baseline)

  41. Telesystolic volume (mL)

    Measured: T0 + 5 weeks

  42. Telesystolic volume (mL)

    Measured: T0 + 3 months

  43. Telediastolic volume (mL)

    Measured: T0 + 5 weeks

  44. Telediastolic volume (mL)

    Measured: T0 + 3 months

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

    Measured: within 3 months post infarction = T0 (baseline)

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

    Measured: T0 + 5 weeks

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

    Measured: T0 + 3 months

  48. Ejection fraction of the left ventricle

    Measured: within 3 months post infarction = T0 (baseline)

  49. Ejection fraction of the left ventricle

    Measured: T0 + 5 weeks

  50. Ejection fraction of the left ventricle

    Measured: T0 + 3 months

  51. S' wave velocity (cm/s)

    Measured: within 3 months post infarction = T0 (baseline)

  52. S' wave velocity (cm/s)

    Measured: T0 + 5 weeks

  53. S' wave velocity (cm/s)

    Measured: T0 + 3 months

  54. E' wave velocity (cm/s)

    Measured: within 3 months post infarction = T0 (baseline)

  55. E' wave velocity (cm/s)

    Measured: T0 + 5 weeks

  56. E' wave velocity (cm/s)

    Measured: T0 + 3 months

  57. A' wave velocity (cm/s)

    Measured: within 3 months post infarction = T0 (baseline)

  58. A' wave velocity (cm/s)

    Measured: T0 + 5 weeks

  59. A' wave velocity (cm/s)

    Measured: T0 + 3 months

  60. The E/A ratio

    Measured: within 3 months post infarction = T0 (baseline)

  61. The E/A ratio

    Measured: T0 + 5 weeks

  62. The E/A ratio

    Measured: T0 + 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2016 (estimated)
  2. Study start5 May 2017
  3. Primary completion11 Jul 2019
  4. Study completion11 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02932696
Sponsor's protocol ID
NIMAO/2016-06/AD-01
Acronym
TrainStrain
Status last verified
Oct 2019
First submitted
12 Oct 2016
Last updated
24 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac training program in people with Myocardial Infarction, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The % global longitudinal strain of the left ventricle (time frame: within 3 months post infarction = T0 (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02932696.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.

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