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OpenTrials
Completed

NCT Number: NCT03516643

Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina

This is a prospective cohort study to examine the efficacy of ESMR application in patients with refractory angina despite optimal medical therapy, not suitable for further PCI or CABG. Characteristics such as angina class scores (CCS class score), nitroglycerin consumption and hospitalization were compared at baseline and 1, 6 and 12 months after ESMR therapy. The effect on cardiac perfusion was assessed at 6 months.

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Key information

Conditions

Angina Refractory Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • history of coronary artery disease;
  • refractory angina pectoris, defined as the persistence of a angina pectoris (Canadian Cardiovascular Society class ≥ 2) for more than 3 months, despite the use of optimal medical therapy (which included β blockers, calcium channel blockers, long-acting nitrates, ivabradine, ranolazine and trimetazidine, up-titrated to the maximal tolerated dose) and coronary disease not amenable for further revascularization (as determined by an interventional cardiologist and cardiac surgeon);
  • stable maximal medical therapy for at least 6 weeks;
  • stress-induced ischemia at baseline SPECT;
  • left ventricular ejection fraction higher than 40%;
  • age higher than 18 years.

Exclusion criteria

  • myocardial infarction or unstable angina in the previous 3 months,
  • acute myocarditis, pericarditis, left ventricular thrombus, cardiac malignancies, chronic pulmonary disease (including emphysema and pulmonary fibrosis), endocarditis
  • pregnancy

Treatment and study plan

Extracorporeal Shockwave Myocardial Revascularization

Other

extracorporeal shockwave in ischemic area evaluated by SPECT

Other names: ESMR

Primary outcomes

  1. Improvement of myocardial perfusion

    Time frame: 6months after ESMR

    Reduction in stress-induced ischemia at SPECT

Secondary outcomes

  1. Reduction of symptoms

    Time frame: 1, 6, 12 months

    Improvement of CCS class

  2. Reduction of symptoms

    Time frame: 1, 6, 12 months

    Improvement of NYHA class

  3. Reduction of symptoms

    Time frame: 1, 6, 12 months

    Reduction of oral nitrates need

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Improving Myocardial Perfusion in Refractory Angina. Extracorporeal Shockwave Myocardial Revascularization in a Large Prospective Cohort

Important dates

Study start
2009
Primary completion
2010
Study completion
2018
First posted
May 4, 2018
Registry last updated
May 4, 2018

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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