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New treatment option for Ischemic Heart Disease
Official title ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO
ClinicalTrials.gov ID: NCT03563417
What this study is testing
- What it's testing
- Study design Prospective randomized open labeled multicenter study Hypotheses 1. In asymptomatic patients with ≥ 10% of myocardial ischemia: PCI (Percutaneous Coronary Intervention) with latest generation of drug eluting stents is superior to optimal medical therapy in terms of relative reduction in MACCE (Major Adverse Cardiovascular and Cerebrovascular events).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- CTO in native coronary artery
- Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.
- Age ≥18 yrs.
- Able to provide written informed consent and willing to comply with the specified follow-up contacts.
- Target artery ≥ 2.5 mm Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into: Cohort A...
You likely can't join if
- NSTEMI or STEMI within 1 month
- Coronary anatomy not suitable for CTO-procedure
- Coronary disease involving the left main/three vessel disease with indication for CABG following heart team conference.
- Life expectancy \< 2 years
- Severe chronic pulmonary disease (FEV1 \< 30 % of predicted value)
- Contraindication to dual anti-platelet therapy
See the full eligibility criteria
- CTO in native coronary artery
- Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.
- Age ≥18 yrs.
- Able to provide written informed consent and willing to comply with the specified follow-up contacts.
- Target artery ≥ 2.5 mm Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into: Cohort A: Asymptomatic (CCS \ 60) patients with myocardial ischemia (≥ 10% of LV) in...
- NSTEMI or STEMI within 1 month
- Coronary anatomy not suitable for CTO-procedure
- Coronary disease involving the left main/three vessel disease with indication for CABG following heart team conference.
- Life expectancy \< 2 years
- Severe chronic pulmonary disease (FEV1 \< 30 % of predicted value)
- Contraindication to dual anti-platelet therapy
- Pregnancy
- eGFR \< 30 mL/min/1.73 m2
- In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.
- Severe valvular heart disease
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Denmark
- Copenhagen, Denmark
- Hellerup, Denmark
- Odense, Denmark
- Roskilde, Denmark
- Tallinn, Estonia
- Helsinki, Finland
- Kuopio, Finland
- Tampere, Finland
- Turku, Finland
- Essey-lès-Nancy, France
- Grenoble, France
- Badalona, Barcelona, Spain
- Galdakao, Bizkaia, Spain
- Barcelona, Spain
- Madrid, Spain
- Tarragona, Spain
- Gothenburg, Sweden
- Lund, Sweden
- Stockholm, Sweden
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Denmark; Copenhagen, Denmark; Hellerup, Denmark; Odense, Denmark; Roskilde, Denmark; Tallinn, Estonia and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.