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Coronary Artery Dissection, Spontaneous | Statin and Angiotensin-converting Enzyme Inhibitor on Symptoms in Patients With SCAD

Coronary Artery Dissection, Spontaneous research study

What is the primary objective of this study?

An emerging cause of heart attack in young women is a dissection (or tear) in the coronary arteries. Many of these young women continue to have chest pain long after the tear has healed and this is thought to be due to problems with their small blood vessels of the heart (or microcirculation). We want to determine whether commonly used medications for coronary artery disease including statins (for cholesterol) and angiotensin-converting enzyme inhibitors (for blood pressure) reduce chest pain and improve small vessel function in these patients.

Who is eligible to participate?

Inclusion Criteria: - Any woman with prior SCAD who is at least 3 months out from her SCAD and has ongoing symptoms of chest pain. - Females of child-bearing age must have a negative pregnancy test at enrollment - Coronary Flow Reserve(CFR) < 3.0 Exclusion Criteria: - Renal dysfunction with Glomerular Filtration Rate <50 ml/min - Patients not willing to undergo coronary angiography - Patients with a prior intolerance or allergy to rosuvastatin or ramipril - Inability to perform CRT or CFR >3.0 - Obstructive coronary artery disease (stenosis >50% in any artery) or residual dissection >50% with distal flow abnormalities

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Coronary Artery Dissection, Spontaneous

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ramipril5-10mg (starting dose 5mg titrating up to 10mg if tolerated after 1 week)

Drug:rosuvastatin10-20mg (suggested dose 10mg for Asians, 20mg for everyone else)

Drug:placeboPlacebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Rosuvastatin, placeborosuvastatin 10-20mg daily or placebo (suggested dose of 10mg for Asians, and 20mg for others)

Ramipril, placeboramipril (starting dose of ramipril at 5mg daily titrating up to 10mg daily at 1 week if tolerated) versus placebo

Study Status

Recruiting

Start Date: June 2014

Completed Date: June 2021

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Angina frequency domain of the SAQ

Secondary Outcome: Acute coronary syndrome or hospitalization for angina

Study sponsors, principal investigator, and references

Principal Investigator: Tara Sedlak, MD

Lead Sponsor: Cardiology Research UBC

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02008786

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