Comprehensive Cardiac CT versus Exercise Testing in Suspected Coronary Artery Disease (CRESCENT II Trial)

Comprehensive Cardiac CT versus Exercise Testing in Suspected Coronary Artery Disease (CRESCENT II Trial) - CRESCENT II

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40120

Enrollment

250

Registered

2013-05-29

Start date

2013-07-12

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary disease

Interventions

COMPREHENSIVE CARDIAC CT (INTERVENTION), to be completed depending on the results: [1] CORONARY CALCIUM SCAN (CT-CALCIUM) [2] CT CORONARY ANGIOGRAPHY (CT-ANGIO) [3] CT MYOCARDIAL PERFUSION IMAGING (

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Stable chest pain, requiring evaluation of coronary artery disease

Exclusion criteria

Exclusion criteria: History of CAD: prior myocardial infarction or revascularization procedure (CABG or PCI) Contra-indication to radiation exposure (CT/SPECT): pregnancy Contra-indication to iodine contrast media: renal failure, iodine allergy Contra-indications to adenosine

Design outcomes

Primary

Measure	Time frame
Rate of negative invasive catheterization procedures (superiority) Proportion of invasive angiograms without relevant coronary artery disease. A positive invasive angiogram is defined as: CAD with a class I indication for myocardial revascularization, in accordance with clinical guidelines [Wijns]. This indication will be assessed independently, in a blinded fashion, regardless of the clinical decision made by the treating physician: * Left main coronary stenosis >50% with objective ischemia. * Proximal LAD stenosis >50% with objective ischemia. * Two or three vessel disease with impaired LV function and objective ischemia. * Proven large area of ischemia (>10% LV) * Any stenosis >50% with limiting anginal symptoms unresponsive to optimal medical treatment.	—

Measure

Time frame

Rate of negative invasive catheterization procedures (superiority) Proportion of invasive angiograms without relevant coronary artery disease. A positive invasive angiogram is defined as: CAD with a class I indication for myocardial revascularization, in accordance with clinical guidelines [Wijns]. This indication will be assessed independently, in a blinded fashion, regardless of the clinical decision made by the treating physician: * Left main coronary stenosis >50% with objective ischemia. * Proximal LAD stenosis >50% with objective ischemia. * Two or three vessel disease with impaired LV function and objective ischemia. * Proven large area of ischemia (>10% LV) * Any stenosis >50% with limiting anginal symptoms unresponsive to optimal medical treatment.

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Secondary

Measure	Time frame
* Number of patients with class I coronary artery disease on invasive angiography * Positive yield of invasive coronary angiography: proportion angiograms with class I CAD. * Number of diagnostic procedures and related expenses per patient (at 6 months). * Therapeutical expenses (medication, revascularizations) per patient (at 6 months). * Overall medical expenses (at 6 months). * Time until (final) diagnosis and treatment decision. * Chest pain symptoms and quality of life (at six months). * Composite major adverse event rate: cardiac death, non-fatal acute coronary syndrome, cerebro-vascular events. * Cost-effectiveness (incremental cost-effectiveness ratio, net health benefit) * Proportion of tests with diagnostic results * Cumulative radiation exposure * Diagnostic complications: allergic reactions, bleeding, arrhythmia, renal dysfunction.	—

Measure

Time frame

* Number of patients with class I coronary artery disease on invasive angiography * Positive yield of invasive coronary angiography: proportion angiograms with class I CAD. * Number of diagnostic procedures and related expenses per patient (at 6 months). * Therapeutical expenses (medication, revascularizations) per patient (at 6 months). * Overall medical expenses (at 6 months). * Time until (final) diagnosis and treatment decision. * Chest pain symptoms and quality of life (at six months). * Composite major adverse event rate: cardiac death, non-fatal acute coronary syndrome, cerebro-vascular events. * Cost-effectiveness (incremental cost-effectiveness ratio, net health benefit) * Proportion of tests with diagnostic results * Cumulative radiation exposure * Diagnostic complications: allergic reactions, bleeding, arrhythmia, renal dysfunction.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)