Role of Endothelin in Microvascular Dysfunction Following PCI for NSTEMI

Completed · Phase 2 · Has a placebo group

Conditions studied: Myocardial Reperfusion Injury

In brief

Percutaneous coronary intervention (PCI) for acute coronary syndromes frequently fails to restore myocardial perfusion despite establishing epicardial vessel patency. Endothelin-1 (ET-1) is a potent vasoconstrictor and its expression is increased in atherosclerotic coronary arteries. Our hypothesis is that increased activity of the endogenous endothelin system contributes to microvascular dysfunction, and adjunctive therapy with an endothelin receptor antagonist will result in improved microvascular blood flow. Aims: The aims of the study are to assess in patients with non ST-elevation myocardial infarction, whether: 1) PCI causes an increase in coronary blood ET-1 level; 2) an endothelin receptor antagonist acutely improves coronary microvascular blood flow following PCI. Non-ST segment elevation myocardial infarction (NSTEMI) is one type of heart attack. It is defined as the development of heart muscle necrosis results from an acute interruption of blood supply to a part of the heart which is demonstrated by an elevation of cardiac markers Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) in the blood and the absence of ST-segment elevation in ECG (electrocardiography). ST-segment is a portion of ECG, its elevation indicates full thickness damage of heart muscle. Absence of ST-segment elevation in NSTEMI indicates partial thickness damage of heart muscle occurs. Therefore, NSTEMI is less severe type of heart attack compared to STEMI (ST-segment elevation myocardial infarction) in which full thickness damage of heart muscle occurs.

Key facts

Study ID

NCT00586820

Run by

Mayo Clinic

People needed

23

Starts

2005-05-01

Expected to finish

2012-01-01

Last updated by the study team

2014-07-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Clinical diagnosis of unstable angina or non ST-elevation myocardial infarction, and requiring clinically indicated PCI for the management of non ST elevation acute coronary syndrome.

You may not qualify if…

• Systemic hypotension (systolic <90 mmHg)
• Heart failure or known ejection fraction < 30%
• Left main disease
• Culprit lesion is in a saphenous vein graft
• 100% occlusion of the culprit vessel or culprit is an ostial right coronary stenosis
• Currently enrolled in other active cardiovascular investigational studies
• Severe endocrine, hepatic, or renal disorders
• Pregnancy or lactation
• Federal Medical Center inmates
• Inability or unwillingness to provide informed consent

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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